Latest news with #Skovronsky
Yahoo
09-05-2025
- Business
- Yahoo
Governor breaks ground on $4.5 billion Lilly Medicine Foundry in Lebanon
Gov. Mike Braun visited Lebanon Tuesday to help break ground for the $4.5 billion Eli Lilly Medicine Foundry in Lebanon. The foundry is the first research and development site of its kind in the world and will combine research, process development, and clinical trial manufacturing in a single site. It represents the most strategic capital investment in the nation's pharma supply chain in a generation, Lilly Chairman and CEO Dave Ricks said. Lilly has pledged $100 million in scholarships to train its own workforce. Braun said the foundry will create a pipeline of opportunity for Indiana's university graduates and strengthen America's pharmaceutical supply chain, as it returns pharmaceutical production back to the United States. At the Foundry, Lilly scientists will research and make lifesaving medicines to replace injectable drugs for genetic and other diseases, Lilly Chief Scientific Officer and President of Lilly Research Laboratories and Lilly Immunology Dr. Daniel Skovronsky said. Lilly built a pilot mini-foundry 20 years ago, and the diabetes drug Trulicity blossomed out of research there, along with a new breakthrough medicine to treat Alzheimer's disease and others, Skovronsky said. Lilly scientists plan to develop complex drugs that combine elements in new ways that have never been combined before to treat conditions including ovarian cancer. Ovarian cancer accounts for only 2% of female cancers but causes a disproportionate number of deaths. 'We think we can fix that,' Skovronsky said. State and county leaders came together Tuesday to turn dirt with red shovels at the site south of Ind. 32 on Lebanon's west side. Braun thanked Lebanon Mayor Matthew Gentry for helping draw Lilly to Lebanon. 'The groundbreaking of Eli Lilly's Medicine Foundry marks a transformative moment for Lebanon and American manufacturing,' Gentry said afterward. 'With a $4.5 billion investment, this facility will create 400 high-skill jobs. The Medicine Foundry will not only deliver high-quality jobs but also provide opportunities for local small businesses, including contractors, caterers, and service providers, ensuring that our entire community thrives into the future. 'This facility bolsters our nation's ability to produce critical medicines domestically, reflecting the values of hard work and independence that define our community and state,' he added.
CNN
17-04-2025
- Health
- CNN
Eli Lilly says experimental GLP-1 pill helped people with diabetes lose weight and lower blood sugar
Drugmaker Eli Lilly said Thursday that an experimental pill form of popular GLP-1 medications helped people with type 2 diabetes lose an average of nearly 8% of their body weight after 40 weeks and lowered their A1C levels. Lilly, which makes the injectable drugs Zepbound to treat obesity and Mounjaro and Trulicity to treat diabetes, is among several companies chasing an effective pill form of GLP-1s. The only such pill available so far comes with strict diet restrictions. Lilly's announcement comes on the heels of an announcement from Pfizer, which said Monday that it was ending development of its daily pill treatment for obesity. A patient in the clinical trial had a possible liver injury that was no longer a problem once they stopped taking that drug, Pfizer said. In 2020, the US Food and Drug Administration approved Novo Nordisk's Rybelsus for treatment of type 2 diabetes, but it has to be taken on an empty stomach. Some doctors also report that Rybelsus may not be as effective as injections yet still comes with side effects. Lilly says that no such diet restrictions are needed with its experimental oral medication, orforglipron, and that it's the first drug of its kind to complete a Phase 3 trial. the Indianapolis company said that in a study of more than 550 people, orforglipron reduced weight by an average of 16 pounds (7.9%) among people who had type 2 diabetes with inadequate glycemic control with diet and exercise alone, and who were using the highest dose of the medication. The participants were still losing weight by the end of the 40-week trial. The trial also achieved its primary goal of lowering participants' A1C level – a measurement of the average amount of glucose in blood over the previous three months – more than a placebo. Participants saw an average reduction of 1.3% to 1.6% from a baseline of 8%. Glucose, or blood sugar, is the body's main source of energy. People who have diabetes can't make enough insulin, a hormone the pancreas makes to help the body keep blood sugar levels in a certain range. People with type 2 diabetes may also have cells that are resistant to the effects of insulin. GLP-1 drugs help control blood sugar by stimulating the pancreas to release insulin and suppressing the release of another hormone. GLP-1s also help reduce the feeling of hunger and can make people feel full for longer. Orforglipron helped more than 65% of trial participants get to or maintain their A1C at or under 6.5%, the level at which people are considered to have diabetes, Lilly said. Dr. Dan Skovronsky, Lilly's chief scientific officer, said Wednesday that even before the trial results were released within the company, he knew they would be good. 'When I walked into the room to see the results, I saw everybody smiling, so I knew they were about to share good news with me,' he said. Liver injury like what was seen in the trial of the Pfizer drug is always possible with small-molecule drugs like this one, Skovronsky said, and it is difficult to detect whether it will cause a problem until the drug is tested in enough people. 'We did not see a liver safety signal with ours, which was a relief,' Skovronsky said. Side effects with the pill were similar to those reported with injectable forms of GLP-1 drugs. The adverse events were considered generally mild to moderate, according to the company, with upset stomach the most commonly reported. Many people who use injectable GLP-1s eventually quit because of side effects. But by the end of this trial, Skovronsky said, more than 90% of the participants had stuck with the medication. GLP-1 injections are highly effective, but for many people, they are cost-prohibitive. The injections are also complicated and costly to make. A daily pill would be easier to use and, because it would be cheaper to manufacture, could possibly lower patient costs, expert say. It's too early to know how much orforglipron might cost if it's approved. Injection drugs have other downsides, as well. They need to be refrigerated and require plastic applications, whereas pills have less packaging. 'Drugs in tablet form are valuable for a lot of patients for a lot of reasons, particularly those who are needle-phobic,' said Dr. Amy Rothberg, a clinical professor of medicine in the Division of Metabolism, Endocrinology & Diabetes in the Department of Internal Medicine and a research professor of nutritional sciences in the School of Public Health at the University of Michigan. 'And it probably just simplifies things to just add on another pill, as opposed to taking a shot, which is a little more complex.' Rothberg, who was not involved with the new trial, hopes Lilly will pass on cost savings to patients if the drug is approved. 'We could reach many more people then,' she said. A growing number of people do need treatment for diabetes or obesity. More than 40% of US adults live with obesity, and about 11.6% of the population – an estimated 38.4 million Americans – had been diagnosed with diabetes as of 2021, according to the US Centers for Disease Control and Prevention. Most have type 2 diabetes. Skovronsky said that Lilly has already been producing orforglipron pills after getting earlier promising results assuming that the rest of the trials will go well. 'That way, we'll have adequate supply to meet demand,' he said. Lilly plans to publish the results of its late-stage trial in a peer-reviewed journal and expects to share more results later this year, along with findings from another clinical trial program that it created to evaluate the drug for its weight management qualities. It's also testing to see if a pill might improve people's high blood pressure and sleep apnea, two conditions that have been helped with certain injectable GLP-1s. Lilly said it expects to apply for approval of orforglipron for weight management by the end of the year and submit results concerning its treatment of type 2 diabetes in 2026.
Yahoo
17-04-2025
- Health
- Yahoo
Experimental GLP-1 pill helped people with diabetes lose weight and lower blood sugar, Eli Lilly says
Drugmaker Eli Lilly said Thursday that an experimental pill form of popular GLP-1 medications helped people with type 2 diabetes lose an average of nearly 8% of their body weight after 40 weeks and lowered their A1C levels. Lilly, which makes the injectable drugs Zepbound to treat obesity and Mounjaro and Trulicity to treat diabetes, is among several companies chasing an effective pill form of GLP-1s. The only such pill available so far comes with strict diet restrictions. Lilly's announcement comes on the heels of an announcement from Pfizer, which said Monday that it was ending development of its daily pill treatment for obesity. A patient in the clinical trial had a possible liver injury that was no longer a problem once they stopped taking that drug, Pfizer said. In 2020, the US Food and Drug Administration approved Novo Nordisk's Rybelsus for treatment of type 2 diabetes, but it has to be taken on an empty stomach. Some doctors also report that Rybelsus may not be as effective as injections yet still comes with side effects. Lilly says that no such diet restrictions are needed with its experimental oral medication, orforglipron, and that it's the first drug of its kind to complete a Phase 3 trial. the Indianapolis company said that in a study of more than 550 people, orforglipron reduced weight by an average of 16 pounds (7.9%) among people who had type 2 diabetes with inadequate glycemic control with diet and exercise alone, and who were using the highest dose of the medication. The participants were still losing weight by the end of the 40-week trial. The trial also achieved its primary goal of lowering participants' A1C level – a measurement of the average amount of glucose in blood over the previous three months – more than a placebo. Participants saw an average reduction of 1.3% to 1.6% from a baseline of 8%. Glucose, or blood sugar, is the body's main source of energy. People who have diabetes can't make enough insulin, a hormone the pancreas makes to help the body keep blood sugar levels in a certain range. People with type 2 diabetes may also have cells that are resistant to the effects of insulin. GLP-1 drugs help control blood sugar by stimulating the pancreas to release insulin and suppressing the release of another hormone. GLP-1s also help reduce the feeling of hunger and can make people feel full for longer. Orforglipron helped more than 65% of trial participants get to or maintain their A1C at or under 6.5%, the level at which people are considered to have diabetes, Lilly said. Dr. Dan Skovronsky, Lilly's chief scientific officer, said Wednesday that even before the trial results were released within the company, he knew they would be good. 'When I walked into the room to see the results, I saw everybody smiling, so I knew they were about to share good news with me,' he said. Liver injury like what was seen in the trial of the Pfizer drug is always possible with small-molecule drugs like this one, Skovronsky said, and it is difficult to detect whether it will cause a problem until the drug is tested in enough people. 'We did not see a liver safety signal with ours, which was a relief,' Skovronsky said. Side effects with the pill were similar to those reported with injectable forms of GLP-1 drugs. The adverse events were considered generally mild to moderate, according to the company, with upset stomach the most commonly reported. Many people who use injectable GLP-1s eventually quit because of side effects. But by the end of this trial, Skovronsky said, more than 90% of the participants had stuck with the medication. GLP-1 injections are highly effective, but for many people, they are cost-prohibitive. The injections are also complicated and costly to make. A daily pill would be easier to use and, because it would be cheaper to manufacture, could possibly lower patient costs, expert say. It's too early to know how much orforglipron might cost if it's approved. Injection drugs have other downsides, as well. They need to be refrigerated and require plastic applications, whereas pills have less packaging. 'Drugs in tablet form are valuable for a lot of patients for a lot of reasons, particularly those who are needle-phobic,' said Dr. Amy Rothberg, a clinical professor of medicine in the Division of Metabolism, Endocrinology & Diabetes in the Department of Internal Medicine and a research professor of nutritional sciences in the School of Public Health at the University of Michigan. 'And it probably just simplifies things to just add on another pill, as opposed to taking a shot, which is a little more complex.' Rothberg, who was not involved with the new trial, hopes Lilly will pass on cost savings to patients if the drug is approved. 'We could reach many more people then,' she said. A growing number of people do need treatment for diabetes or obesity. More than 40% of US adults live with obesity, and about 11.6% of the population – an estimated 38.4 million Americans – had been diagnosed with diabetes as of 2021, according to the US Centers for Disease Control and Prevention. Most have type 2 diabetes. Skovronsky said that Lilly has already been producing orforglipron pills after getting earlier promising results assuming that the rest of the trials will go well. 'That way, we'll have adequate supply to meet demand,' he said. Lilly plans to publish the results of its late-stage trial in a peer-reviewed journal and expects to share more results later this year, along with findings from another clinical trial program that it created to evaluate the drug for its weight management qualities. It's also testing to see if a pill might improve people's high blood pressure and sleep apnea, two conditions that have been helped with certain injectable GLP-1s. Lilly said it expects to apply for approval of orforglipron for weight management by the end of the year and submit results concerning its treatment of type 2 diabetes in 2026.
New York Times
17-04-2025
- Health
- New York Times
Daily Pill May Work as Well as Ozempic for Weight Loss and Blood Sugar
A daily pill may be as effective in lowering blood sugar and aiding weight loss in people with Type 2 diabetes as the popular injectable drugs Mounjaro and Ozempic, according to results of a clinical trial announced by Eli Lilly on Thursday morning. The drug, orforglipron, is a GLP-1, a class of drugs that have become blockbusters because of their weight-loss effects. But GLP-1s are expensive, must be kept refrigerated and must be injected. A pill that produces similar results has the potential to become far more widely used. 'In the coming decades, 700 million people around the world will have Type 2 diabetes, and over a billion will have obesity,' said Dr. Daniel Skovronsky, Lilly's chief scientific officer. 'Injections cannot be the solution for billions of people around the world.' The results Lilly announced came from a clinical trial involving 559 people with Type 2 diabetes who took the new pill or a placebo for 40 weeks. In patients who took orforglipron, blood sugar levels fell by 1.3 to 1.6 percent, about the same amount in that time period experienced by patients taking Ozempic and Mounjaro in unrelated trials. For 65 percent of people taking the new pill, blood sugar levels dropped into the normal range. Patients on the new pill also lost weight — up to 16 pounds without reaching a plateau at the study's end. Their weight loss was similar to that achieved in 40 weeks with Ozempic but slightly less than with Mounjaro in unrelated trials. Side effects were the same as those with the injectable obesity drugs — diarrhea, indigestion, constipation, nausea and vomiting. This was the first of seven large clinical trials of orforglipron to report results. Some of the others are testing the drug for weight loss in people without diabetes. The company said it would present these new results at the annual meeting of the American Diabetes Association's Scientific Sessions in June and will publish them in a peer-reviewed journal. Lilly added that it would seek approval from the Food and Drug Administration later this year to market orforglipron for obesity and early in 2026 for diabetes. If the drug is approved for obesity and diabetes, Dr. Skovronsky said, the company is confident it will have sufficient amounts of the pills to meet demand. He said that he had learned the results of the diabetes study on Tuesday morning but that without even knowing them, the company had been preparing supplies. It has built factories and has already made a billion pills. Twelve percent of American adults say they have taken a GLP-1. About 40 percent of Americans are obese, and more than 10 percent have diabetes, most of whom have Type 2, according to the Centers for Disease Control and Prevention. In a way, the very existence of orforglipron is a triumph of modern chemistry. The injectable GLP-1 drugs are peptides — small fragments of proteins. (GLP stands for glucagon-like peptide.) Peptides are digested by the stomach. So, in order to make an oral GLP-1, chemists had to find a way to make a nonpeptide that acts exactly like a peptide. Researchers at Chugai Pharmaceutical Company, a Japanese company, figured out a way, licensing their drug to Lilly in 2018. The solution was to find a small molecule — thousandths of the size of a peptide — that sinks into a tiny pocket in the protein that is the target for GLP-1s. When it sinks into the pocket, the protein changes shape just as it does when a GLP-1 binds to the whole protein. Finding that small molecule, Dr. Skovronsky said, was 'the holy grail.' The result — a pill that can be taken at any time of day, with or without food — is almost unheard-of in the world of peptide drugs. Insulin, probably the most common peptide drug, has been around for more than 50 years. It is still only an injectable despite intense efforts by scientists to make an insulin pill. So is human growth hormone. So are drugs used to treat a wide variety of diseases, including arthritis and cancer. Novo Nordisk has a GLP-1 pill, Rybelsus, but it contains the GLP-1 peptide, so it must be taken in large doses and is not as effective as the injectables because most of it is digested. But for patients with diabetes and those struggling with obesity, a pill that can replace an injection can be transformative, for several reasons. One is that it can make treatments attractive to those who cannot bear very idea of injecting themselves. Dr. C. Ronald Kahn, a professor of medicine at Harvard and chief academic officer at Harvard's Joslin Diabetes Center, said he had many patients who were reluctant to inject themselves with Ozempic or Mounjaro. A pill, he said, 'would definitely be preferred by most people.' Dr. Sean Wharton, director of the Wharton Medical Clinic in Burlington, Ontario, has a broader hope. Dr. Wharton, who enrolled patients in Lilly's study of orforglipron for obesity, said a pill could potentially bring GLP-1 treatment to underserved populations throughout the world. 'It can be easily made in a factory and shipped everywhere,' he said. It should cost much less to make than peptides and does not require packaging in special injection pens. It does not have to be kept refrigerated. For now, only rich countries have had access to GLP-1 drugs, and even in those countries, the drugs are available only to a small portion of people. 'Here we have a chance of a medicine being given to millions and millions of people,' Dr. Wharton said. But that depends on Eli Lilly and how it chooses to price and distribute its drug. 'That's why I emphasize the word 'chance,'' Dr. Wharton said.
CNN
17-04-2025
- Health
- CNN
Experimental GLP-1 pill helped people with diabetes lose weight and lower blood sugar, Eli Lilly says
Drugmaker Eli Lilly said Thursday that an experimental pill form of popular GLP-1 medications helped people with type 2 diabetes lose an average of nearly 8% of their body weight after 40 weeks and lowered their A1C levels. Lilly, which makes the injectable drugs Zepbound to treat obesity and Mounjaro and Trulicity to treat diabetes, is among several companies chasing an effective pill form of GLP-1s. The only such pill available so far comes with strict diet restrictions. Lilly's announcement comes on the heels of an announcement from Pfizer, which said Monday that it was ending development of its daily pill treatment for obesity. A patient in the clinical trial had a possible liver injury that was no longer a problem once they stopped taking that drug, Pfizer said. In 2020, the US Food and Drug Administration approved Novo Nordisk's Rybelsus for treatment of type 2 diabetes, but it has to be taken on an empty stomach. Some doctors also report that Rybelsus may not be as effective as injections yet still comes with side effects. Lilly says that no such diet restrictions are needed with its experimental oral medication, orforglipron, and that it's the first drug of its kind to complete a Phase 3 trial. the Indianapolis company said that in a study of more than 550 people, orforglipron reduced weight by an average of 16 pounds (7.9%) among people who had type 2 diabetes with inadequate glycemic control with diet and exercise alone, and who were using the highest dose of the medication. The participants were still losing weight by the end of the 40-week trial. The trial also achieved its primary goal of lowering participants' A1C level – a measurement of the average amount of glucose in blood over the previous three months – more than a placebo. Participants saw an average reduction of 1.3% to 1.6% from a baseline of 8%. Glucose, or blood sugar, is the body's main source of energy. People who have diabetes can't make enough insulin, a hormone the pancreas makes to help the body keep blood sugar levels in a certain range. People with type 2 diabetes may also have cells that are resistant to the effects of insulin. GLP-1 drugs help control blood sugar by stimulating the pancreas to release insulin and suppressing the release of another hormone. GLP-1s also help reduce the feeling of hunger and can make people feel full for longer. Orforglipron helped more than 65% of trial participants get to or maintain their A1C at or under 6.5%, the level at which people are considered to have diabetes, Lilly said. Dr. Dan Skovronsky, Lilly's chief scientific officer, said Wednesday that even before the trial results were released within the company, he knew they would be good. 'When I walked into the room to see the results, I saw everybody smiling, so I knew they were about to share good news with me,' he said. Liver injury like what was seen in the trial of the Pfizer drug is always possible with small-molecule drugs like this one, Skovronsky said, and it is difficult to detect whether it will cause a problem until the drug is tested in enough people. 'We did not see a liver safety signal with ours, which was a relief,' Skovronsky said. Side effects with the pill were similar to those reported with injectable forms of GLP-1 drugs. The adverse events were considered generally mild to moderate, according to the company, with upset stomach the most commonly reported. Many people who use injectable GLP-1s eventually quit because of side effects. But by the end of this trial, Skovronsky said, more than 90% of the participants had stuck with the medication. GLP-1 injections are highly effective, but for many people, they are cost-prohibitive. The injections are also complicated and costly to make. A daily pill would be easier to use and, because it would be cheaper to manufacture, could possibly lower patient costs, expert say. It's too early to know how much orforglipron might cost if it's approved. Injection drugs have other downsides, as well. They need to be refrigerated and require plastic applications, whereas pills have less packaging. 'Drugs in tablet form are valuable for a lot of patients for a lot of reasons, particularly those who are needle-phobic,' said Dr. Amy Rothberg, a clinical professor of medicine in the Division of Metabolism, Endocrinology & Diabetes in the Department of Internal Medicine and a research professor of nutritional sciences in the School of Public Health at the University of Michigan. 'And it probably just simplifies things to just add on another pill, as opposed to taking a shot, which is a little more complex.' Rothberg, who was not involved with the new trial, hopes Lilly will pass on cost savings to patients if the drug is approved. 'We could reach many more people then,' she said. A growing number of people do need treatment for diabetes or obesity. More than 40% of US adults live with obesity, and about 11.6% of the population – an estimated 38.4 million Americans – had been diagnosed with diabetes as of 2021, according to the US Centers for Disease Control and Prevention. Most have type 2 diabetes. Skovronsky said that Lilly has already been producing orforglipron pills after getting earlier promising results assuming that the rest of the trials will go well. 'That way, we'll have adequate supply to meet demand,' he said. Lilly plans to publish the results of its late-stage trial in a peer-reviewed journal and expects to share more results later this year, along with findings from another clinical trial program that it created to evaluate the drug for its weight management qualities. It's also testing to see if a pill might improve people's high blood pressure and sleep apnea, two conditions that have been helped with certain injectable GLP-1s. Lilly said it expects to apply for approval of orforglipron for weight management by the end of the year and submit results concerning its treatment of type 2 diabetes in 2026.
