Madrigal Pharmaceuticals First to Receive FDA Clearance for a NASH Treatment

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The oral drug will be marketed under the brand name Rezdiffra. This is the first drug approved to treat NASH.

Madrigal Pharmaceuticals has been given Food and Drug Administration market clearance for its experimental treatment for NASH, a fatty liver disease that causes inflammation of the liver, writes John George for Philadelphia Business Journal.

The oral drug will be marketed under the brand name Rezdiffra. This is the first drug approved to treat NASH.

The news on Thursday afternoon led to a 25% increase in Madrigal shares after a temporary decline right before the FDA made the announcement.

“The accelerated approval of Rezdiffra is a culmination of more than 15 years of research from our founder Dr. Becky Taub and a small R&D team that took on one of the biggest challenges in drug development,” said Bill Sibold, CEO of Madrigal in a statement.

“This is a historic moment for the NASH field and represents the best of what our industry is capable of.”

Taub, chief medical officer and president of research and development, said that they believe Rezdiffra “will change the treatment paradigm for NASH, giving physicians, a liver-directed therapy to help improve fibrosis and resolve NASH before their patients progress to cirrhosis.”

Other companies previously worked on their own treatments for NASH, but the biggest challenge is finding a drug that addresses the large genetic variations found in patients.

Read more about the FDA approval of Madrigal’s NASH treatment in the Philadelphia Business Journal.

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