- Wegovy gets green light for liver disease
- More than 22 million affected in US
- First GLP-1 drug to get approval
Danish healthcare giant Novo Nordisk (NOVO-B:CPH) rallied as much as 6% after it’s blockbuster weight loss drug Wegovy received US approval to treat a serious liver condition.
The news comes as a welcome relief for Novo shareholders who have seen the shares fall 63% over the last year following sharply reduced growth expectations amid rising competition from Eli Lilly (LLY:NYSE) and copycat weight loss drug manufacturers.
EXTENDED SCOPE
The US FDA (Food and Drug Administration) has granted accelerated approval for Wegovy to treat MASH (Metabolic-dysfunction associated steatohepatitis) in adults with moderate to advanced liver fibrosis.
The approval was based on part one of the ESSENCE clinical trial in which Wegovy demonstrated a ‘significant’ and ‘superior’ improvement in liver fibrosis.
Martin Holst Lange, executive vice president, chief scientific officer and head of research and development at Novo Nordisk, commented: ‘MASH represents a significant health burden, with one in three people with overweight or obesity worldwide affected.
In the US alone, around 22 million people are estimated to live with MASH. With the approval of Wegovy for MASH, we provide a new treatment to people living with MASH that not only halts the disease activity but helps reverse the damage caused to the liver.’
More than 200 million people live with MASH and the number of individuals in advanced stages of the disease is expected to double by 2030.
The company said the treatment will be available immediately in the US and should be used alongside a programme of exercise and diet. Novo has also filed for regulatory approval in the European Union in February 2025, with a subsequent filing in Japan in May.
Wegovy will be the first GLP-1 treatment approved for MASH, and the second FDA approved therapy to treat the disease after Madrigal Pharmaceuticals’ (MDGL:NASDAQ) RezDiffra got the green light in March.
Meanwhile, arch-rival Eli Lilly is expected to launch its own version following positive results from a mid-stage clinical trial in February.
