The U.S. 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 (NASDAQ:MDGL) has succeeded in a disease area that several larger companies have failed — or are still trying to break into. Madrigal shares jumped more than 20% in extended trading Thursday following the approval.
Novo Nordisk (NYSE:NVO) and Eli Lilly (NYSE:LLY) are testing their respective blockbuster weight loss injections as treatments for the same kind of liver disease, called nonalcoholic steatohepatitis, or NASH.
Madrigal’s drug, which will be marketed as Rezdiffra, is specifically approved to treat patients with NASH who also have moderate-to-advanced liver scarring. The treatment must be used with diet and exercise, according to the FDA.
NASH is a serious form of liver disease characterized by excess fat buildup and inflammation in the liver and can lead to liver scarring, also known as fibrosis, along with liver failure and liver cancer. The condition is often associated with other health problems, such as high blood pressure, Type 2 diabetes and obesity.
Roughly six million to eight million people in the U.S. have NASH with moderate-to-advanced liver scarring, according to an estimate cited by the FDA.
MDGL shares leaped $50.07, or 20.6%, to $293.64.
