Novo Nordisk’s Wegovy Gets US Approval For Liver Disease
The shot was cleared for the disease known as MASH, or metabolic-associated steatohepatitis, in adults with moderate to advanced scar tissue in the liver.
Novo Nordisk A/S’s blockbuster weight-loss drug Wegovy received Food and Drug Administration approval to treat a serious form of liver disease, beating rival Eli Lilly & Co. to the US market for the increasingly prevalent condition.
The shot was cleared for the disease known as MASH, or metabolic-associated steatohepatitis, in adults with moderate to advanced scar tissue in the liver. The condition affects about 6% of US adults, or about 14.9 million people, the FDA said in a statement on Friday. The drug is intended to be used in conjunction with a reduced-calorie diet and increased exercise.
The approval gives Novo another first-mover advantage in the booming market for GLP-1 drugs that have been widely popularized for weight loss. Additional uses, like the one for the liver disease, could help expand the market for Novo at a time when competition from less expensive copycats and rival Lilly is fierce.
Novo’s American depositary receipts rose 6% in late trading. Madrigal Pharmaceuticals Inc., which is developing treatments for the same condition, fell about 6.5%.
MASH develops when fat builds up in the liver, causing inflammation and potentially leading to more serious conditions like cirrhosis and liver cancer.
In a study, Wegovy improved liver fibrosis in 37% of patients, without exacerbating inflammation, compared with an improvement in 22% of patients given a placebo. And nearly twice as many patients on the drug had their inflammation resolve compared with those on placebo, the company said in a statement.
About one in three people who are overweight or obese are affected by the condition, Martin Holst Lange, Novo’s chief scientific officer, said in the statement. Wegovy not only halted disease activity in those patients, it helped reverse the damage done to the liver, he said.
