Madrigal Pharma’s Rezdiffra Receives FDA Approval, Driving Surge in Stock Value

Madrigal

Madrigal  the Food and Drug Administration on Thursday approved the first-ever treatment for a common and potentially deadly form of liver disease that affects millions worldwide.
The FDA’s decision means Madrigal Pharmaceuticals has succeeded in a disease area several much larger companies have failed — or are still trying to break into. The company’s shares rose 20% in extended trading Thursday on the news.
Novo Nordisk and Eli Lilly are both testing their blockbuster weight loss shots to cure the same variety of liver disease, known as NASH or nonalcoholic steatohepatitis. The treatment, known as Rezdiffa, has been approved to cure NASH patients with moderate-to-advanced liver scarring. It must be combined with a diet and exercise, according to the FDA.
One of the severe variants of a liver disease, nonalcoholic steatohepatitis (NASH) is characterized by accumulation of fat and inflammation in the liver, leading to liver scarring, liver failure, and liver cancer. Often, the condition is the result of other health issues, such as high blood pressure or Type 2 diabetes, and obesity as another contributor. The Food and Drug Administration reports that NASH with moderate-to-advanced liver scarring can be experienced by 6 million to 8 million people in the U.S.
According to the statement Madrigal made, the drug is going to be available in April, and the company also said that it has set a program assistance up to help people who do not have insurance get Rezdiffra. The cost of this treatment has not been revealed by Madrigal. Dr. Nikolay Nikolov stated that “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage.
The drug from Madrigal was specifically given “accelerated approval” by the FDA. This is a designation that clears drugs faster if they can fill an unmet medical need for serious conditions. The drugmaker, in turn, is required to further study the treatment and verify its clinical benefit . The medication from Madrigal acts by activating a thyroid hormone receptor found in the liver to help reduce fat accumulation. Patients can take the medication by mouth every day .
In a late-stage study published last month, Rezdiffra helped resolve symptoms of NASH and improve liver scarring without making the condition worse. Notably, the rate of serious adverse events was the same in the patient group that took the medication and in the other group that received a placebo. The most common side effects associated with treatment were diarrhea, nausea, and vomiting. In order to avoid the stigmatization of patients, some specialists have begun to refer to NASH as metabolic dysfunction-associated steatohepatitis, or MASH.