US FDA extends review of Rhythm’s drug for brain damage-related obesity

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By Sneha S K

(Reuters) -Rhythm Pharmaceuticals said on Friday the U.S. Food and Drug Administration has extended the review period for expanded approval of its drug to treat a rare form of obesity, caused due to brain damage, by three months.

The FDA extended the review of Imcivree from December 20 to March 20, 2026, the company said. Shares of the company were down 2.5% at $96.06.

The agency’s notification was “cryptic” and the extension “unexpected and incredibly disappointing,” CEO David Meeker said on a call with analysts.

Rhythm said the health regulator had in October requested additional sensitivity analyses of efficacy data from a late-stage trial testing the drug in patients with acquired hypothalamic obesity.

The condition is caused by damage to the hypothalamus in the brain, often due to tumors, their treatment or other injuries.

The additional information has been deemed a ‘major amendment,’ Rhythm said on Friday, which allows for more time for the agency to review.

The major amendment did not include any information relating to the safety or manufacturing of Imcivree, chemically known as setmelanotide, the drugmaker said, adding that no new data was requested.

“We have every confidence that these additional sensitivity analyses confirm the strength of the data,” Meeker said in a statement.

In April, Imcivree notably reduced weight in patients with the form of obesity in a late-stage trial with 120 patients.

Analysts had earlier said that an approval to treat hypothalamic obesity is highly likely, but they expect uptake to be modest. Rhythm estimates there are about 10,000 patients in the U.S. with the condition.

The drug is currently approved to treat genetic obesity in adults and children aged two years and older.

(Reporting by Sneha S K in Bengaluru; Editing by Sahal Muhammed)