(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.
Rhythm said the health regulator had in October requested more 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,’ which allows for more time for the agency to review, the company said.
The major amendment sought 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 and setmelanotide’s potential to benefit patients with hypothalamic obesity,” said CEO David Meeker.
In April, Imcivree notably reduced weight in patients with the form of obesity in a late-stage trial with 120 patients.
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)
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