Late yesterday FDA granted Wegovy (semaglutide 2.4 mg) a big new indication – treatment of MASH. The indication FDA approved reads as follows:

“For the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults.

“The indication for MASH is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.”

This makes Wegovy the first obesity medicine with an indication for treating liver disease. It’s a big deal simply because MASH is a big – and growing – problem for health. MASH can lead to liver failure and cancer. With growing prevalence of childhood obesity, it can start early in life and go undetected until it reaches an advanced stage that makes it hard to treat.

This indication targets an important unmet medical need.

Only One Other Alternative

The only other medicine approved for treating MASH is Rezdiffra (resmetirom). Though we often talk about Wegovy as being expensive, the pricing of Rezdiffra ranges much higher – up to $4,800 per month. Nonetheless, Rezdiffra is selling briskly, generating revenue of $213 million for the second quarter of this year for Madrigal pharmaceuticals. As with the treatment of obesity, there is plenty of room to grow for drugs that address the need for MASH treatment. More obesity drugs will likely come for this indication.

A Chronic Complication of a Chronic Disease

But the real importance of this new indication is that it will help build the understanding that treating obesity is all about gaining health, not just losing weight. Thus it requires long-term therapy because obesity and its complications are chronic diseases.

This understanding is growing, but it has a long way to go.

Click here, here, and here for more on this new indication for Wegovy.

Liver Vaults, photograph by Rodhullandemu, licensed under CC BY-SA 4.0