Latest news with #Hemgenix
Daily Mail
22-06-2025
- Health
- Daily Mail
Revealed: The most eye-wateringly pricey drugs that the NHS is paying some £3million a dose for...while dementia and cancer patients are denied cheaper treatments
NHS bosses are paying millions of pounds for just a single dose of medication to treat some of the most devastating health conditions in the world. The drugs—some of which cost just shy of £3million per patient—can revolutionise and even save the lives of a handful of people born with rare illnesses each year. But it comes as Government officials have deemed cheaper treatments for far more common conditions like dementia and breast cancer as not worth the money. Libmeldy is widely cited as the most expensive drug available on the NHS, coming in at an eye-watering £2.875million per dose. It's used to treat babies with a fatal genetic disease called metachromatic leukodystrophy (MLD). While born seemingly perfectly healthy, children with MLD have a faulty gene that leads to a destructive build-up of fat around their nerves. Over time, this severely damages their brain and nervous system, with parents forced to watch helplessly as their child gradually stops walking, talking and then eating. Roughly four babies are born with MLD every year in the UK, and have a life expectancy of just five to eight years. But Libmeldy, a one-off treatment administered as an IV drip in hospital, uses a specially designed harmless virus to alter a patients' cells and remove the faulty gene that drives MLD. It's a bespoke treatment that uses a patient's individual cells, meaning a dose is unique to each individual. Another treatment that works in a similar way is Hemgenix, which MailOnline revealed was administered for the first time by the NHS earlier week. The drug —which costs an estimated £2.6million per patient—is also a gene therapy, delivered as one-off IV drip. It is the only treatment of its kind for haemophilia B, a bleeding disorder where the body doesn't make enough—or any—of a vital protein critical to clotting. Clotting stops wounds from bleeding, so those with the disorder risk suffering severe and even life-threatening blood loss from even minor injuries. Patients also run the risk of what are called 'spontaneous bleeds', which can be triggered without a direct injury and even prove deadly if they occur in a vital organ. Prior to Hemgenix, all haemophilia B patients needed regular weekly injections of an artificial clotting agent to keep their risk of catastrophic injury to a minimum. This meant many patients were effectively tethered to their scheduled injections, unable to live their lives without worry and anxiety about every potential nick and scrape. Similar to Libmeldy, Hemgenix works by replacing a patient's defective gene—which is incapable of producing the clotting protein—with one that can, eliminating the need for regular injections. Studies suggest the protective effect lasts for at least three years, but the hope is that it could work for even longer. There are approximately 2,000 people with haemophilia B in the UK. Yet, only around 260 with 'moderately severe or severe haemophilia B' are currently eligible for Hemgenix on the NHS. This puts the potential total bill to the taxpayer at roughly £676million. While a cost of £2.6million per patient may seem prohibitive, medics claim the treating patients this way actually saves the NHS money in the long term. The lifetime cost of providing a patient the alternative weekly clotting injections has been estimated to be £8million. This sum doesn't include the cost of life-saving interventions and surgeries haemophilia B patients may also need. Another multi-million drug approved for use on the NHS is Zolgensma, which comes in at £1.8million per dose. It's designed to help babies with spinal muscular atrophy (SMA), a genetic disease that typically kills within two years if left untreated. Around 56 babies are born with SMA each year, with the condition caused by a defective gene that plays a critical role in allowing nerves in the spinal cord to control muscles movement. SMA causes muscles to waste and gets worse over time, making it difficult for patients to breathe, move and eat. Nine in 10 of those who have the most severe form of the disease, known as type 1, die by the age of two if they do not receive treatment. Zolgensma is given as one off infusion—that like the previously discussed gene therapies—also fixes the faulty gene that drives SMA. Gene therapies are incredibly expensive medications due to the intense design and manufacturing process that goes into their creation. Additionally, because many of them benefit rare health conditions with small patient populations there is an argument that companies need to charge high prices to recoup costs given the drug may only be used a handful of times per year. But exactly how much the NHS pays for these drugs isn't clear. While the companies which make the drugs do charge millions for them, the health service often acquires the medications at an undisclosed discount, so the actual cost is likely to be less than it first appears. Which drugs get funded on the NHS in England and Wales is determined by the NHS spending watchdog, The National Institute for Health and Care Excellence (NICE). In making its decisions, NICE considers a multitude of factors. These include a drug's clinical impact—how much it improves or alleviates a patient's condition—as well as risk of side effects, practical issues like specialist storage, if there are alternatives, and, critically, how much it costs. It then judges if funding the drug will overall provides value for taxpayer money. This is often summarised using a metric called a quality-adjusted life year (QALY), essentially how much it costs to give a patient a healthy year of life. Lecanemab (pictured) and donanemab are currently only available to Brits who can afford to pay around £60,000 privately every year at select clinics Generally, if a drug costs about £20,000 to £30,000 per QALY NICE usually assesses it as a good use of taxpayer funding. This isn't a hard limit. The watchdog can rule drugs that are expensive and only work for a limited time, like end-of-life medications as worth the cost, recognising small amounts of time can be worth a lot to patients and their families. However, this process isn't an an exact science and can attract controversy. For example, the breast cancer drug Enhertu, described as a lifeline by campaigners, has been deemed too expensive by NICE for what it does. However, Scotland's equivalent of NICE—the Scottish Medicines Consortium—has deemed the £10,000 per patient per month drug as value for money. Research suggests Enhertu extends the lives of patients with one of the hardest to treat forms of breast cancer, buying them an extra year or more of life. Given as an infusion, it helps patients with an aggressive and fast-growing type of the cancer called HER2-positive. NICE previously accused the firm behind the drug, AstraZeneca, of refusing to 'offer a fair price'. About 57,000 cases of breast cancer are diagnosed in the UK each year with HER2-positive cancers accounting for roughly one in five of these, some 11,500. Other drugs that have attracted controversy after being rejected by NICE are donanemab and lecanemab. Both medications are designed slow down the early stages of Alzheimer's disease, the leading cause of dementia. The drugs bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's, helping to clear out the substance and slowing cognitive decline. However—in its most recent ruling—NICE said while the treatments worked they only delayed the progression from mild to moderate Alzheimer's by four to six months. As such, the body ruled the medications cannot be provided on the NHS because they are not good value for money and 'only provide modest benefits at best'. Charities described the decision as 'disappointing' and a 'painful setback' for patients, while the firms Lilly, which makes donanemab, and Eisai, which makes lecanemab, said they would appeal the ruling. Alzheimer's is the most common cause of dementia in the UK with 944,000 Britons estimated to be living with the memory robbing disorder. NHS England published a briefing paper last year suggesting the cost of bringing the drugs to the health service could be £500 million to £1 billion per year. While multi-million purchases of single dose drugs using taxpayer funds—as people with far more common condition are denied cheaper medications—may raise eyebrows, the cost is worth putting into context. The NHS purchasing a one off dose of a £2.875million to save a child who would otherwise die, costs roughly 4p per person in the UK. This sum is about half of £5million the NHS in England spends on dishing out the over-the-counter painkiller paracetamol every month, despite the health service banning GPs from prescribing such cheap drugs to patients in 2018.
Daily Mail
18-06-2025
- Health
- Daily Mail
EXCLUSIVE 'I've dreamed of this moment': First ever patient gets 'world's most expensive drug' on the NHS - it costs £2.6million per dose
A 44-year-old man has become the first ever patient to receive a life-changing dose of the 'world's most expensive drug' on the NHS. Called Hemgenix, the drug—which costs an estimated £2.6million per patient—was administered yesterday at St Thomas' NHS Foundation Trust in London. Delivered as a one-off IV drip, it is the only treatment of its kind for haemophilia B. This is a bleeding disorder where the body doesn't make enough—or any—of a vital protein critical to clotting. Clotting stops wounds from bleeding, so those with the disorder risk suffering severe and even life-threatening blood loss from even minor injuries. Patients also run the risk of what are called 'spontaneous bleeds', which can be triggered without a direct injury and even prove deadly if they occur in a vital organ. Prior to Hemgenix, all haemophilia B patients needed regular weekly injections of an artificial clotting agent to keep their risk of catastrophic injury to a minimum. The patient, speaking anonymously, was diagnosed with haemophilia B when he was just 18 months old, and said he was now looking forward to a life 'free of worry'. 'I've always had to be more cautious and to plan ahead. There is a level of anxiety in that and being overly cautious has often led to missed opportunities and things I can't do, like contact sports,' he told MailOnline. 'To experience a life free of the worry and to do things that I wouldn't normally do will also be amazing.' He added: 'Not needing to plan ahead for treatment deliveries or looking up hospitals in foreign destinations when going on holiday, or having to tell people "sorry I can't do that I've got haemophilia", will be something I've always dreamed of.' Medics and charities have hailed the roll-out of the therapy as a critical milestone for helping those with the condition lead more fulfilling lives. Dr Pu-Lin Luo, the consultant haematologist at Guy's and St Thomas' who administered the treatment yesterday said it represented an 'exciting' step in treating the condition. 'This is a big step forward in our ability to manage haemophilia B and could change the lives of some of our patients. 'It is also a testament to the advancement of cell and gene therapies in the UK,' she said. Kate Burt, chief executive of charity The Haemophilia Society, also added: 'Today marks an important milestone not just for this patient, but for all those living with haemophilia B in the UK.' 'The current treatment of lifelong intravenous injections can place a significant burden on those living with haemophilia and it has an impact on broader family, relationships and work. 'The availability of gene therapy for haemophilia B as a one-time infusion will allow those eligible for treatment to expand their horizons and live life to the full, free from the restrictions of regular injections.' Despite being approved for use on the NHS last year, yesterday's treatment is the first time Hemgenix has been used by the health service. It's also the first time the drug has been used in the UK outside of a clinical trial. Hemgenix is the brand name of the drug etranacogene dezaparvovec. It works by replacing a patient's defective gene—which is incapable of producing the clotting protein—with one that can, eliminating the need for regular injections. Studies on the gene therapy have shown the protective effect lasts for at least three years, but the hope is it could work for even longer. There are approximately 2,000 people with haemophilia B in the UK. Yet only around 260 with 'moderately severe or severe haemophilia B' are currently eligible for Hemgenix on the NHS. This puts the potential total bill to the taxpayer at about £676million. MailOnline understands, however, that the NHS acquired the drug at an undisclosed discount, so the actual cost is likely to be less. Additionally, while the cost of the drug is roughly £2.6million per patient, medics claim the treatment actually saves the NHS money in the long term. The lifetime cost of providing a patient the alternative weekly clotting injections has been estimated to be £8million. This sum doesn't include the cost of life-saving interventions and surgeries haemophilia B may also need. Hemgenix is made by Philadelphia-based pharmaceutical company CSL Behring. Reacting to the news today the firm's general manager for UK and Ireland, Eduardo Cabas, said: 'This patient receiving etranacogene dezaparvovec is a testament to the collaborative efforts of the haemophilia community, NICE and NHS England to ensure that patients in the UK are able to access this one-time treatment option.' Hemgenix was initially described as the 'most expensive drug in the world' when it originally came onto the scene in 2022. However, other drugs—also gene therapies—have since eclipsed it in terms of overall cost. Like all medications Hemgenix does come with the risk of side effects. Patients administered the drug take regular liver function tests to ensure the vital organ is functioning correctly. This is because there is a risk the medication could trigger a potentially dangerous immune response. These tests are held one a week for the first three months before they are reduced to once a year. Patient information leaflets distributed with the drug also highlight a potential increased risk of cancer due to the fact it inserts itself into the DNA of cells. However, clinical studies have—so far—shown no cancers have been caused by Hemgenix use. Those taking Hemgenix must also use contraceptives like condoms for at least a year following treatment, due to a process called 'shedding'—where the drug can be passed through bodily fluids like semen. Patients are also forbidden from donating blood for this reason.
Yahoo
13-05-2025
- Health
- Yahoo
Top 10 most expensive prescription drugs in the US by price and by sales volume
On the heels of President Donald Trump's Monday announcement of an executive order that will slash prescription drug prices in the U.S., the spotlight is on current costs and how much Americans could save. The president's order calls for "most favored nations drug pricing" — which means "the lowest price paid for a drug in other developed countries, that is the price that Americans will pay," he said. "Some prescription drug and pharmaceutical prices will be reduced almost immediately by 50 to 80 to 90%," Trump said. President Trump Takes On 'Big Pharma' By Signing Executive Order To Lower Drug Prices Katy Dubinsky, a New York pharmacist and founder and CEO of Vitalize, applauded the move to reduce prescription prices, noting that Trump's order tackles a long-standing problem. "But this will not be simple to accomplish," she told Fox News Digital. Read On The Fox News App "The executive order doesn't reduce costs immediately," she said. "It directs government agencies to start drafting the rules, which may take months." Here are the five most expensive prescription drugs in the U.S. by price — followed by five by volume. Dubinsky detailed some of the most expensive prescription drugs in the country today and what conditions they treat. 1. Lenmeldy (atidarsagene autotemcel) by Orchard Therapeutics – $4.25 million This medication is used to treat metachromatic leukodystrophy (MLD), a rare genetic disorder that damages the nervous system, Dubinsky said. "It is given once and is supposed to stop or slow down the disease in young kids," she noted. Top 10 'Allergy Capitals' Of The Us, Plus 4 Tips To Manage Symptoms 2. Hemgenix (etranacogene dezaparvovec-drlb) by CSL Behring – $3.5 million This medication is prescribed for people with hemophilia B, a bleeding disorder. "This one-time treatment helps the body make its own clotting factor, so patients don't need regular infusions," said Dubinsky. 3. Elevidys (delandistrogene moxeparvovec-rokl) by Sarepta Therapeutics – $3.2 million This prescription medication, intended for young boys, treats Duchenne muscular dystrophy (DMD), a condition that weakens muscles over time. "It aims to slow down how fast the disease progresses," Dubinsky said. 4. Skysona (elivaldogene autotemcel) by Bluebird Bio – $3 million "This medication is used for cerebral adrenoleukodystrophy (CALD), a serious brain disease in boys," said Dubinsky. "This therapy tries to slow the damage before symptoms get worse." 5. Zynteglo (betibeglogene autotemcel) by Bluebird Bio – $2.8 million Zynteglo is for beta-thalassemia, a blood condition that usually requires regular transfusions. "This gene therapy can help patients make healthy red blood cells on their own and reduce how often they need treatment," said Dubinsky. John Stanford, executive director of Incubate, a Washington-based coalition of early-stage life-science investors, shared his thoughts on the top five most expensive drugs by sales volume. "Typically, when the government is focused on the most expensive drugs, they're focused on the metric based on sales volume rather than, for instance, a rare disease therapy with a high list price but smaller patient pool," he told Fox News Digital. "Often, officials are focused on total drug spending by Medicare or other government programs." 1. Keytruda (pembrolizumab) by Merck — $25 billion revenue (2023) Keytruda is an immunotherapy medication used to treat a variety of cancers, including melanoma, non-small cell lung cancer, liver cancer and others. "Keytruda has become Merck's crown jewel, helping the company expand its cancer treatment portfolio with more than 1,000 active clinical trials," Stanford told Fox News Digital. Terminal Colon Cancer Patient Saved By Breakthrough Treatment 2. Eliquis (apixaban) by Bristol Myers Squibb and Pfizer — $18.95 billion Eliquis (apixaban) is an "anchor drug" for both BMS and Pfizer, according to Stanford. Apixaban is prescribed to prevent the formation of blood clots and to treat deep vein thrombosis and pulmonary embolism (a blood clot in the lungs). 3. Ozempic (semaglutide) by Novo Nordisk — $13.93 billion Prescribed for type 2 diabetes, the semaglutide medication Ozempic has become widely popular for its weight-loss effects and other health benefits. "Ozempic's sales are powering Novo Nordisk's broader foray into GLP-1s for obesity, heart disease and liver conditions — all areas with high development costs and uncertain scientific outcomes," Stanford told Fox News Digital. "The money has gone toward scaling up production to meet demand for GLP-1s and avoid supply shortages." 4. Humira (AbbVie) — $14.4 billion (U.S. 2023 revenue) "Humira has been one of the highest-grossing drugs in history, generating over $200 billion during its exclusivity period," Stanford said. The injectable medication, which contains the active ingredient adalimumab, is used to treat rheumatoid arthritis and other inflammatory conditions. Click Here To Sign Up For Our Health Newsletter 5. Biktarvy by Gilead — $11.85 billion Biktarvy is an HIV treatment that includes the three ingredients bictegravir, emtricitabine and tenofovir alafenamide. "Biktarvy isn't just a leading HIV treatment — it's the financial backbone for Gilead's move into cancer research," Stanford said. Dr. Jacob Glanville, CEO of Centivax, a San Francisco biotechnology company, said vaccines and most generic drugs would not likely be changed by the executive order. "Most vaccines that Americans take cost less than a hundred dollars, while generic drugs are often less than a dollar a pill," he told Fox News Digital. What would be affected, Glanville predicted, are newer brand-name drugs still under IP exclusivity, antibody therapies, cellular therapies, gene therapies and personalized cancer vaccines. "Some of these are excruciatingly expensive — $100,000 to $500,000 for a treatment course for a patient. However, they are also often the most effective treatments for certain cancers, autoimmune disorders or rare diseases." The pharmaceutical industry might argue that lowering the prices on these medicines will result in a "dramatic reduction of investment" in creating such breakthroughs, said Glanville. The industry may also argue that these medicines eventually become generic — at which point the prices drop, according to the expert. For more Health articles, visit "From a patient's perspective, the price of medical care in the United States is unsustainable, and extremely expensive medicine is part of that," he said. But "the insurance system and the hospital business also contribute." "If the prices of new medicines are capped, then effort should be made to reduce the cost of clinical trials and drug GMP manufacturing. Otherwise, we will lose a lot of innovation." Greg Norman of Fox News Digital contributed article source: Top 10 most expensive prescription drugs in the US by price and by sales volume
Medscape
12-05-2025
- Health
- Medscape
Hemophilia B: Post-Beqvez, What's Next for Gene Therapy?
In the spring of 2024, the US Food and Drug Administration (FDA) approved fidanacogene elaparvovec (Beqvez), only the second gene therapy product for hemophilia B. Just a few months later, the Pfizer treatment — expected to cost $3.5 million for a one-time dose — got a boost from a phase 3 study published in The New England Journal of Medicine that found annualized bleeding rates fell by 71% in 45 treated men, although 21% resumed prophylaxis. Then, in April 2025, a follow-up analysis of patients from a phase 1-2a study appeared in NEJM . It tracked 14 patients for at least 3 years and reported none had serious treatment-related adverse events after year 1. The newer findings were good news, but they came too late to matter. Pfizer had killed off Beqvez 2 months earlier. 'The company said the discontinuation was due to several reasons,' Reuters news service reported, 'including limited interest in gene therapies for the bleeding disorder.' (Pfizer had earlier dumped a gene therapy for hemophilia A, also blaming a lack of interest.) In fact, it appears that Beqvez was never administered outside clinical research. What does the loss of this treatment mean for the estimated 7250 patients with hemophilia B in the United States and the hematologists who treat them? Here are some questions and answers about the state of gene therapy in hemophilia B. How Does Gene Therapy for Hemophilia Work? Gene therapy, which is now FDA-approved for hemophilia A and hemophilia B, deliver genes for factor VIII or IX via adeno-associated viruses. The liver then begins producing factor, potentially allowing patients to stop or reduce their use of prophylactic therapy. 'In the best-case scenario, [gene therapy] will provide factor levels in the normal range and essentially normal hemostasis without having to give yourself medication for many years,' explained pediatric hematologist Benjamin Jacob Samelson-Jones, MD, PhD, of the Perelman School of Medicine at the University of Pennsylvania and Children's Hospital of Philadelphia, both in Philadelphia, in an interview for a January 2025 Medscape Medical News article. What Made Beqvez Unique? Not a lot compared with its sole competitor. The FDA approved etranacogene dezaparvovec (Hemgenix), the first gene therapy for hemophilia B, in November 2022. It remains available. Beqvez required a smaller dose, and this was thought to be a potential benefit, said hemophilia specialist Steven Pipe, MD, professor of pediatrics and pathology at the University of Michigan, Ann Arbor, Michigan, in an interview. 'There was a hypothesis that lower dosing could provide a theoretical safety advantage — less vector-related toxicity that may manifest with liver toxicity or the overall number of DNA integration events.' (In gene therapy, 'potential integration of therapeutic transgene into host cell genomes is a serious risk' that can lead to mutations and the creation of tumors, according to a 2023 report.) Safety data have not shown a 'clear signal' of a difference in liver toxicity between the therapies, Pipe said. 'Still, we had hoped that clinicians could have a choice to put before patients.' Were There Other Differences Between Beqvez and Hemgenix? According to Pipe, 'the patient eligibility is reduced compared to Hemgenix since it requires patients to have neutralizing antibody (Nab) titers < 1:5 against the SPK100 vector. Best estimates are that 60% of those screened would be eligible. Nab positivity was not an exclusion for Hemgenix.' The costs for the treatments were both around $3.5 million. Why Didn't Beqvez Catch On? 'There are probably multiple reasons for this, including high cost, logistical challenges for centers wanting to offer gene therapy, caution on the part of patients about long-term safety, and the availability of other good treatment options,' said Adam Cuker, MD, professor of medicine in the Department of Pathology and Laboratory Medicine and chief of the Section of Hematology at the University of Pennsylvania, in an interview. He led the 2024 NEJM phase 3 study of Beqvez. In an interview, Samelson-Jones said it's a shame that Beqvez left the market. 'Worldwide, having two safe and very effective gene therapies for hemophilia B would have decreased costs and increased patient access in the long run. To me, this is why this is a loss to the community.' How Do Competing, Non-Gene Therapy Treatments Fit Into the Picture? The FDA recently approved several new subcutaneous treatments as therapies for both hemophilia A and hemophilia B: Marstacimab (Hympavzi), fitusiran (Qfitlia), and concizumab (Alhemo). 'These drugs add to the growing list of treatment options for patients with hemophilia B,' Cuker said. 'It would not be surprising if some patients who otherwise would have been interested in gene therapy choose one of these subcutaneous treatments instead.' Subcutaneous therapy 'may decrease treatment burden enough that a one-and-done treatment like gene therapy is less attractive,' Samelson-Jones said. 'Hympavzi and other new nonfactor therapies may be a bridge that patients want to try before committing to gene therapy. However, nothing prevents bleeding like factor IX, which is what gene therapy provides.' What Should Hematologists Know About Gene Therapy in Hemophilia B? 'The data for gene therapy in hemophilia B are robust,' Cuker said. 'They show impressive efficacy with a durable response in most patients and a favorable safety profile. For my patients who have received gene therapy, the results have been nothing short of life-changing.' He added: 'Patients with hemophilia B deserve to hear about gene therapy as a treatment option from their hemophilia provider. If a patient is potentially eligible for and interested in gene therapy and it is not offered at their home institution, they should be referred to a center with expertise and experience in gene therapy.' What's Next for Gene Therapy in Hemophilia B? Regeneron is exploring second-generation factor IX gene therapy that relies on gene editing, Pipe said. 'This protocol is looking to establish durable, stable expression. If safe and effective, it has the potential to treat pediatric patients.' An ongoing trial seeks to enroll 120 patients and to conclude by April 2026. Meanwhile, another therapy under investigation 'harvests the patient's own B cells by apheresis,' Pipe said. 'The cells are gene edited at a manufacturing facility so that they express factor IX, then the cells are differentiated to long-lasting plasma cells and given back to the same patient. No immunosuppression required since this is autologous cellular therapy.' This therapy 'as the potential for repeat treatment if expression declines over years and can also be dose-titrated to desired expression level,' Pipe said. Be Biopharma has begun a trial of this therapy.
Yahoo
28-03-2025
- Health
- Yahoo
US FDA approves Sanofi's bleeding disorder therapy
(Reuters) -The U.S. Food and Drug Administration approved French drugmaker Sanofi's hemophilia therapy, paving the way for a new type of treatment for patients with the rare blood clotting disorder, the regulator said on Friday. Sanofi's subcutaneous, or under-the-skin, therapy helps prevent bleeding and lowers antithrombin, a protein that delays blood clotting, for hemophilia patients aged 12 years and older. It is a first-in-class, antithrombin-lowering therapy for people with hemophilia A or B, with or without inhibitors. The hemophilia market has been dominated by factor replacement therapies for decades. However, recently, gene therapies such as CSL's Hemgenix and BioMarin Pharmaceutical's Roctavian have been approved as an alternative in the United States. Sanofi's therapy Qfitlia is to be used once every two months, compared to other available treatments such as Pfizer's once-a-week injection Hympavzi and Novo Nordisk's once-daily Alhemo. "Today's approval of Qfitlia is significant for patients with hemophilia because it can be administered less frequently than other existing options," said Tanya Wroblewski, deputy director of the Division of Non-Malignant Hematology in the FDA's Center for Drug Evaluation and Research.
