(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

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