MDGL Surged, AS FDA Approved Its Drug's Treatment for Liver Disease
The FDA has approved the first-ever treatment for a common and potentially fatal liver disease that affects millions of people worldwide.
This FDA decision means that $Madrigal Pharmaceuticals(MDGL)$ has scored a major victory in a disease area where several big companies have failed or are still struggling to get in. Following the approval, Madrigal's stock price jumped over 20%.
$Novo-Nordisk A/S(NVO)$ and $Eli Lilly(LLY)$ are testing their heavyweight weight-loss injections to treat nonalcoholic steatohepatitis (NASH).
Madrigal's drug, to be marketed as Rezdiffra, is specifically designed for NASH patients with moderate to severe liver scarring. The FDA says this treatment must be combined with diet and exercise.
NASH is a serious liver condition characterized by excessive fat accumulation and inflammation, which can lead to liver scarring (fibrosis), liver failure, and liver cancer. It's often linked to other health issues like hypertension, type 2 diabetes, and obesity.
According to estimates cited by the FDA, there are approximately 6 to 8 million people in the US with NASH and moderate to severe liver scarring.
Madrigal stated that the drug will be available in April. The company also mentioned setting up an assistance program to help uninsured people access Rezdiffra.
"Previously, NASH patients with significant liver scarring had no drugs that directly addressed liver damage," said Dr. Nikolay Nikolov, Acting Director of the Office of Immunology and Inflammation at the FDA.
Madrigal's drug received the FDA's "accelerated approval" designation, which allows for faster approval when a drug addresses an unmet medical need for a serious condition. It also requires the manufacturer to further study the treatment and verify its clinical benefits.
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