US FDA greenlights GSK's drug for UTIs in women and girls
March 25 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved GSK's (GSK.L), opens new tab drug for a common type of urinary tract infection (UTI) in women and adolescent girls, one of five new approvals the British drugmaker has been expecting this year.
The antibiotic, branded as Blujepa, is approved for women aged 12 years and older to treat uncomplicated UTIs, which are bacterial infections affecting the lower urinary tract in otherwise healthy individuals.
here.
GSK plans to launch the drug in the U.S. in the second half of the year, and did not disclose details on pricing.
GSK is banking on new drugs in its infectious diseases portfolio, including its recently launched respiratory syncytial virus vaccine, to make up for lost revenues from its best-selling medicines and looming patent losses for its HIV treatments.
Over half of all women will experience uncomplicated UTIs in their lifetime, and around 30% will suffer at least one recurrent episode, according to GSK.
The drug chemically known as gepotidacin is designed to target the most common UTI-causing bacteria such as E. coli, the company said.
The drug acts on a different part of the bacteria compared to most other antibiotics, making it effective against organisms resistant to current treatments, according to GSK.
The bacteria is also less likely to develop resistance to the drug, as it would need to mutate in both the enzymes that gepotidacin targets, according to GSK.
Antimicrobial resistance, where bacteria withstand the drugs designed to kill them, results in over 2.8 million infections annually in the United States, according to the CDC.
The approval was based on data from two late-stage trials showing the drug was superior to nitrofurantoin, the standard-of-care medication introduced in the 1950s.
In one of GSK's studies, gepotidacin achieved complete disease resolution in 58.5% of patients compared with 43.6% for nitrofurantoin.
The drug's development was partly funded by multiple U.S. government grants, GSK said.
The FDA in October last year approved another oral antibiotic, Orlynvah, developed by Irish biotech firm Iterum Therapeutics, for the treatment of certain types of bacterial UTIs in adult women.
GSK's chief scientific officer Tony Wood said on a call ahead of the FDA approval that the drug's method of action against the main type of bacteria causing UTIs made it competitive against Iterum's medicine.
While GSK has not given a sales target for Blujepa, it has said it expects the medicine, along with two other medicines in development, Brexafemme and tebipenem, to generate peak year sales of more than 2 billion pounds ($2.59 billion).
($1 = 0.7721 pounds)
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Reuters
8 hours ago
- Reuters
Otsuka's kidney disease therapy trial results heat up battle with rival Vera
June 6 (Reuters) - Otsuka's (4578.T), opens new tab experimental therapy for a potentially life-threatening kidney disease more than halved severe levels of protein in the urine of patients, intensifying the battle for an effective new treatment with rival Vera Therapeutics (VERA.O), opens new tab. The Japan-based company said on Friday its therapy, sibeprenlimab, cut proteinuria levels by 51.2% in patients with Immunoglobulin A Nephropathy, also known as Berger's disease, at nine months in a late-stage trial. The data comes just days after Vera said its drug, atacicept, reduced protein levels in patients' urine by 46%, compared with a 7% reduction with a placebo, meeting the main goal of a 428-patient late-stage study. Shares of the U.S.-based drug developer slid 31% to $20.89. Analysts, however, said that though data from Otsuka's sibeprenlimab might look superior, it was unlikely that doctors would interpret it that way. The difference between the two datasets is not too clinically diverse to affect demand for Vera's drug, said Jefferies analyst Farzin Haque. Berger's disease causes abnormal protein buildup in the kidneys and could eventually lead to the organ's failure. Analysts have estimated the U.S. market for its treatments could be worth as much as $10 billion. Otsuka has already applied for the FDA's accelerated approval for its therapy to treat the disease. However, its sales would largely depend on whether the treatment can improve kidney function, analysts said. Even if the drug gains accelerated approval, Otsuka said it plans to study whether it can preserve the organ's ability to filter toxins from blood, measured as the glomerular filtration rate (eGFR). "The magnitude of the protein reduction should translate into eGFR preservation down the line, because ultimately that's what patients are going to be asking for," Dana Rizk, the trial's investigator and a professor of medicine at the University of Alabama in Birmingham, told Reuters. The study is expected to be completed in early 2026.
Telegraph
9 hours ago
- Telegraph
My elderly parents have become cantankerous and refuse to listen to reason
Dear A&E, My parents, who are in their 70s, are driving my three siblings and me mad. They are vague with information, complain endlessly about everything but don't seem to want any actual solutions. They have various health issues but they just moan about the doctors without seeing anything through. They are panicking about money but don't want any support: one minute they are selling their house and the next they are not. How can we make them handle things more practically, or let us do it for them? – Infuriated Dear Infuriated, We have a feeling that a lot of people reading your dilemma will be saying, 'Hmm'. Why? Well, it just might be that you are at Everest base camp, complaining about the altitude and the cold, rather than looking up and thinking, 'Holy hell – this is the easy bit. We are going to have to equip ourselves to get up that mountain – as a team.' Brace yourself, Infuriated: your parents are only going to get more frustrating and, probably, crosser. Information is only going to become more opaque. They will likely continue to ignore your advice, and you have no real idea how it's all going to play out. You have little agency here. And, quite frankly (here's the shocking bit), they may be old, but it's still their life and their business. We are telling you right at the top of this column: choose love. Let go of any illusion that you are going to somehow wrestle control, or that you are going to say one thing and all the cards are going to magically fall into place. Instead, be a sympathetic ear, listen without judgment and don't wear yourself out before you even start the real climb. Do you remember what it was like being a teenager? You might have teenagers now and are watching them do all sorts of stupid things (as you once did). Did you listen to advice then? Are your teenagers taking notes and nodding enthusiastically as you dispense your wisdom, telling them they should put their studies first or eat more greens or go for a walk? What you wanted from your parents then was just love and minimal intervention, and this is what they want from you now: an understanding ally for when getting a doctor's appointment is impossible, the hospital parking is impossible and the price of whatever is impossible. They don't want your projections or your spreadsheets, just as you didn't want theirs. Sometimes all you need to do is learn how to listen to people complain or wobble, without immediately leaping to offer advice or to fix it. It's also important to remember that your parents, frustrating and teetering as they may be, might not be ready to sign over their lives; to hand over their decisions; to sell the home they have spent 50 years maintaining. Even though you may feel strongly that you're right, it's a decision that you would make within the context of your life right now – when you are busy and organised and energised. You may not make the same decision 35 years down the line. So, deep breaths. Listen. If you are still desperate to 'help', you could try a subtle approach. When they're not in the middle of downloading their discontent while also rejecting any advice, you might be able to say something like, 'By the way, if you would like to create a bible of all your passwords, bank accounts and insurance details, so it's all there for you in one place, I'd be really happy to do it.' Make these kinds of suggestions far away from any exasperation or conflict, not when they're moaning about something you've heard them drone on about before, while you are already fizzing and furious. Instead, try 'I was just thinking, would it be helpful if I did this?' You might get a no every time. But one yes might slip through. We know this is not easy, dear Irritated. While you are busy trying and failing to take care of them in the way you wish to, you are also going to have to honour your own sense of being a child. Respect the fact that, while you're responding as a frustrated midlifer who understands things such as power of attorney, you're also responding as a teenager who finds everything your parents do intolerable, and as a five-year-old who loves them more than you love anyone – and thinks that they can solve every problem in the world. All those things are happening at the same time. And that is what makes this painful. Love your parents and communicate with your siblings, because this is only going to get more arduous and, ultimately, sad. You and your siblings should try to be a cohesive, united front who can share and support each other, whatever is coming your way. Your parents are going to do what they are going to do. It might get hairy, but really, after all is said and done, you want to be left with good relationships. Choose love, not lectures; and look for the glimmers. You will need them to see you through this.
Daily Mail
11 hours ago
- Daily Mail
10 foods you didn't realize contained disease-causing food additives
The so-called 'Skittles ban,' signed by Gavin Newsom in 2023 banned four food additives that have been linked to kidney, thyroid and gastrointestinal cancer and mood disorders. California's law is a big step forward in protecting Americans from dangerous chemicals in foods and health officials and experts are calling on other states, and the federal government, to follow its lead. The four banned additives in the Golden State are: brominated vegetable oil, potassium bromate, propylparaben and red dye No.3. Diet and citrus sodas: Brominated vegetable oil. When you reach for a refreshing bubbly drink beware you also could be reaching for brominated vegetable (BVO), one of the additives banned in California. The ingredient often shows up in diet and citrus sodas to stop ingredients in fruit-flavored soft drinks from separating. BVO hasn't been declared a carcinogen and it is still allowed to be used in foods, though the US Food and Drug Administration (FDA) has said the ingredient should be consumed only on an interim basis. Exposure to BVO can irritate the nose, throat, lungs and the mucous membranes inside the mouth, throat, stomach and lungs. Repeated and long term exposure to the chemical can also cause neurological issues like memory loss, impaired balance and coordination and headaches and in rodent studies, the animals had high tissue levels of bromine, which posed a danger to thyroid health. Chocolate candies and flavored chips: Artificial colors. Some popular brands of bite-sized chocolate candies and sweetly flavored chips get their signature hues and flavor from artificial coloring, including Red 3, included in California's new bill, Blue 1, Blue 2, Yellow 5, Yellow 6 and Red 40. While the additives may make these foods eye-catching and tasty, they can also make them harmful to your health. Some research has shown these dyes are associated with allergies and asthma and a recent study in mice linked Red 40 to inflammatory bowel disease. The National Institutes of Health (NIH) has reported that Red 3 causes cancer in animals and there is evidence several other dyes are carcinogenic. Red 40, Yellow 5 and Yellow 6 have been found to be contaminated with benzidine and other carcinogens. Additionally, at least four dyes - Blue 1, Red 40, Yellow 5 and Yellow 6 - cause hypersensitivity reactions, with studies showing consumption of artificial food coloring produces statistically significant increases in ADHD symptoms in children. Red 3 specifically has been found to cause cancer and thyroid tumors in lab animals and has been linked to hyperactivity and other neurobehavioral effects in children. But the ingredient, which has been banned in the European Union, China and India because of its dangerous impact on health, has been shown to cause nose, throat and lung irritation. It has also been shown in lab tests to cause renal and thyroid tumors to form in rats. Cheeses, pickles, syrups, jams and wines: Propylparaben. The fourth and last additive included in California's new ban is propylparaben. That charcuterie board at your next housewarming party may look appetizing and be jam packed with the classics, but a wine and cheese night should be enjoyed with caution. Propylparaben occurs as a natural substance in plants and some insects. It is typically used in a variety of water-based cosmetics and personal-care products, as well as a food additive. The substance, however, has been shown to cause endocrine disruption and reproductive issues. However, the FDA has said the substance is generally regarded as safe. Lunch and processed meats: Heterocyclic amines and polycyclic aromatic hydrocarbons. Classified as carcinogens, lunch meats and processed meats like hot dogs, sausage and bacon contain two ingredients called heterocyclic amines and polycyclic aromatic hydrocarbons (PAHs). Heterocyclic amines are mutagenic chemicals that form when cooking muscle meats, such as beef, pork, chicken and fish. They are some of the most potent mutagens and have shown to induce tumors in animal models. PAHs are chemicals that occur naturally in coal, crude oil and gasoline. They come from burning coal, oil, gas, wood, garbage and tobacco and the high heat needed to cook meat will form PAHs. PAHs, however, may cause cancer and harm the eyes, kidneys and liver. Potato chips and French fries: Acrylamide. While your guilty pleasure may be diving into a bag of potato chips on the couch or you find yourself hitting the drive-thru to satisfy a craving for french fries, these two foods should be eaten with caution because they contain acrylamide. Acrylamide is a substance that can form through a natural chemical reaction in some foods during high-temperature cooking, such as frying, roasting and baking. However, in the body, acrylamide is converted into a compound called glycidamide, which causes mutations in and damage to the DNA. Additionally, studies in rodent models have found exposure to the substance increases the risk for several types of cancer. Gummy and sour candies: Titanium dioxide. With Halloween right around the corner, store shelves are stocked with candy favorites. And while trick-or-treaters may want to fill their bags with classic sour and gummy treats, they should heed caution before unwrapping their night's reapings. These popular candies contain titanium dioxide, a substance that has been shown to cause irritation of the eyes, nose and throat. Exposure to it in animal studies also showed it to cause lung cancer. This compound is banned in Europe over concerns its particles have genotoxic effects — or the ability to directly damage a person's DNA. However, the FDA still allows it in Americans' foods. Ice cream and cream cheese: rBGH and rBST. If you prefer cream cheese over butter on your bagel or indulge in a scoop or two of ice cream after dinner, you could unknowingly be consuming potentially harmful hormones. Recombinate bovine growth hormone (rBGH) or recombinate bovine somatotropin (rBST) is a synthetic version of a hormone cows produce to regulate certain metabolic processes. It has been marketed to dairy farmers to increase milk production in cows and has been approved by the FDA since 1993, but is banned in Europe and Canada. Research into the hormone's link to breast cancer has produced mixed results but the use of rBST has been shown to increase levels of insulin-like growth factor, a protein found naturally in milk. Some studies have shown insulin-like growth factor to be linked to prostate, breast and colorectal cancers. Bread and flour: Azodicarbonamide. Not only do bagels, bread, pastries and tortillas contain the harmful potassium bromate, these products, along with hamburger and hot dog buns, also have azodicarbonamide, or ADA, in them. This ingredient is a chemical compound approved by the FDA to use as a whitening agent and is used to strengthen and enhance the elasticity of dough in cereal flour and bread dough. It is sometimes called the 'yoga mat' chemical because it is widely used in foamed plastics. The additive is banned in Europe and Australia. While not classified as a carcinogen, some case reports and epidemiological studies in humans have produced evidence the compound can induce asthma and respiratory symptoms, as well as skin irritation. Sugary cereals: BHA and BHT. Sugary cereals may be appealing to kids - and kids at heart - but they contain the ingredients butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT). BHA is a synthetic petrochemical used widely as a preservative in cereals and other dry goods. BHT is used in similar products and helps fats in foods stay fresher longer. BHA is considered a carcinogen and has been shown to promote tumor growth and impair blood clotting. It also acts as an endocrine disruptor and is associated with the underdevelopment of the reproductive system. BHA and BHT both pose a threat to the circulatory system and BHT can impact testosterone levels.
