Rezdiffra Launches as First MASH Treatment with Promising Rapid Uptakes

Madrigal Pharmaceuticals' new drug, Rezdiffra, has recently been approved as the first treatment for metabolic dysfunction-associated steatohepatitis (MASH). Gastroenterologists, are highly optimistic about its potential in managing patients with moderate to advanced fibrosis and suffering from severe liver conditions such as cirrhosis.

The following article originally appeared in Fierce Pharma.

Madrigal Pharmaceuticals already has physicians singing from its hymn sheet. Shortly after the biotech won approval in metabolic dysfunction-associated steatohepatitis (MASH), most gastroenterologists said they were familiar with its drug and planning to trial the brand within six months of its launch.

Spherix Global Insights captured the views in a survey that asked 81 gastroenterologists for their opinion on the liver disease drug and projected uptake of the brand post-launch. More than 80% of the doctors reported unaided awareness of Rezdiffra’s approval. Seventy percent of the respondents said they are at least moderately familiar with Rezdiffra, a significant increase over the awareness level one year ago.

More than three-quarters of the gastroenterologists expect to trial the brand within six months of its launch. The gastroenterologists said more than one-third of the MASH patients they look after are eligible for the drug, a finding Spherix said further bolsters the chances of swift uptake and utilization.

Interest in Rezdiffra reflects the fact it is the first MASH treatment and evidence that it can improve liver scarring. One physician told Spherix it is “nice to have a daily oral pill to help reduce hepatosteatosis and possibly reverse liver damage,” while another gastroenterologist noted the “good safety profile.”

Spherix heard some dissenting voices, though. One respondent commented on some gastrointestinal side effects and efficacy data that suggest the drug will fail “a large number” of patients. Another person called the list price—$47,400—“problematic,” adding that “we will have to see what third-party payer barriers are thrown up to its use.”

Madrigal said the “price reflects value as first-and-only therapy for NASH” when it won approval. The biotech pointed to best-in-class health economics and outcomes research data along with the experience of its team to contend it can handle the market access side of the launch. Madrigal is aiming to achieve 80% commercial coverage by the end of 2024 and quickly cut the time to fill prescriptions to 30 days.

The Rezdiffra launch will focus on around 14,000 specialists, including 6,000 “top treaters,” who care for the 315,000 MASH patients with moderate to advanced fibrosis. If Rezdiffra can stop those patients from progressing to cirrhosis, it could prove its value by preventing liver failure, transplants and deaths.

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