The US Food and Drug Administration (FDA) has granted its approval for the first drug for treating a common liver inflammation form known as metabolic dysfunction-associated steatohepatitis (MASH).
MASH Liver Inflammation
MASH, which is also known as NASH (nonalcoholic steatohepatitis), takes place when inflammation occurs in the liver due to excess cells of fat. The condition leads to liver inflammation or damage despite low alcohol use. It is considered an advanced type of nonalcoholic fatty liver disease.
According to the FDA, roughly six million to eight million individuals in the US may have NASH with moderate to advanced liver scarring, or fibrosis. Complications linked to MASH include liver failure, cirrhosis, and liver cancer.
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FDA Approves First Drug For MASH Liver Inflammation
Previously, treatment regimens for NASH mainly focused on weight loss via lifestyle changes, such as adapting a healthy diet, engaging in regular exercise, and controlling blood sugar.
The new FDA-approved drug treatment, resmetirom from Madrigal Pharmaceuticals, will be sold under the Rezdiffra brand name. In April, it was a recipient of the Breakthrough Therapy designation of the FDA. Such a status accelerates drug development and review for medications meant to treat serious conditions, and the initial clinical evidence notes could be a grave improvement compared to available treatments.
The treatment activates the liver's thyroid hormone receptor in order to reduce the accumulation of fat. It is designed for daily oral consumption. The drug has been approved for MASH patients with moderate-to-advanced fibrosis. It is meant to be used with exercise and a healthy diet.
February clinical trial findings revealed that over 25% of the participants who took 80 mg of resmetiron saw NASH resolution without their fibrosis getting worse. This was similarly observed among 30% of individuals who took 100 mg and under 10% of those who took a placebo. The drug was also observed to reduce bad cholesterol levels, or LDL, as well as liver enzyme levels.
In the trial, most adverse events that were noted were quite mild to moderate. The most common ones were diarrhea and nausea.
The FDA also notes that Rezdiffra may have potentially significant interactions with other kinds of drugs, with statins for reducing cholesterol being the most notable one.
The brand was granted accelerated approval. Now, Madrigal should accomplish a post-approval study to verify the clinical benefit of the drug.
Wayne Eskridge, Fatty Liver Foundation's CEO, shares that this approval could offer momentum and energy to the NASH circle, boosting efforts to enhance disease education, expand NASH research investment, and build pathways for care.
According to Madrigal, they expect that the drug will be available in the next month. They have also set up an assistance program to aid individuals without insurance access to the medication.
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