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It has the US Food and Drug Administration. approved The first drug for a common liver inflammation called nonalcoholic steatohepatitis, or NASH, the agency said Thursday.
NASH – also known as metabolic dysfunction-associated steatohepatitis or MASH – occurs when the liver becomes inflamed because excess fat builds up in the liver, leading to inflammation and scarring. Non-alcoholic fatty liver disease is an advanced form; The disease is closely associated with obesity, type 2 diabetes and other metabolic conditions such as high blood pressure. About 6 million to 8 million people in the U.S. are thought to have NASH, with moderate to severe liver fibrosis or scarring, the FDA says. Other complications associated with the disease include cirrhosis, liver failure, and liver cancer.
Until now, there was no medicine to treat the disease. In the past, NASH treatment regimens focused on lifestyle changes such as weight loss through blood sugar control, a healthy diet, and regular exercise.
Madrigal Pharmaceuticals' new drug resmetirom is marketed under the brand name Resdifra. It received Breakthrough Therapy designation from the FDA in April. This will speed up the development and evaluation of drugs intended to treat the serious condition, and preliminary clinical data indicate that it could be a significant improvement over existing treatments.
The drug – which activates thyroid hormone receptors in the liver to help reduce fat deposits – is taken orally every day. It is approved for people with moderate to severe fibrosis, and is intended to be used in conjunction with a healthy diet and exercise.
Clinical trial Results A study published in February found that more than 25% of participants taking 80 mg of resemetrom achieved resolution of NASH without worsening fibrosis, compared to 30% of those taking 100 mg and less than 10% of participants taking placebo. The drug helped lower LDL or “bad” cholesterol levels and liver enzyme levels.
It is not yet clear how long patients need to take the drug. More research is needed.
Most of the adverse events reported in the trial were mild or moderate; Diarrhea and nausea were very common. According to the FDA, rezdifra can cause “potentially beneficial” interactions with certain other medications, especially cholesterol-lowering statins.
Resdifra received what is known as accelerated approval, and Madrigal must complete a post-approval study to confirm the drug's clinical utility.
Wayne Eskridge, CEO of the Fatty Liver Foundation, said: “I believe this milestone will bring new energy and momentum to the NASH community, accelerating our efforts to improve disease education, build pathways to care and expand investment in NASH research. News release from Madrigal on Thursday.
Madrigal said he expects Rezdifra to be available next month and has set up a grant program to help uninsured people get the drug.
Dr. Pierre Golam, Hepatologist It is hoped that the approval of this drug at the University Hospitals in Cleveland will be the first of those that can improve the outcome of this disease. He is happy to finally have something to offer to his patients with this disease.
Because we've been trying to find a drug that works, and the FDA has been approving it for more than 15 years in the broad category of steatotic liver disease or fatty liver disease, but so far all the drugs have been effective. It was not developed for this,” Golam said. “So it's a big deal.”