Author Archives: Marta Figueiredo

Setmelanotide Given FDA Priority Review for POMC and LEPR Deficiency

The U.S. Food and Drug Administration (FDA) has accepted and given priority review to Rhythm Pharmaceuticals’ request that setmelanotide be approved to treat people with POMC deficiency and LEPR deficiency, two rare genetic obesity disorders. This priority status is expected to shorten setmelanotide’s regulatory review to…

Rhythm Seeks FDA Approval of Setmelanotide for POMC/LEPR Deficiency

Rhythm Pharmaceuticals is seeking approval from the U.S. Food and Drug Administration (FDA) for its lead candidate setmelanotide to treat POMC deficiency and LEPR deficiency, two rare genetic obesity disorders. Over the next two months, the FDA will determine whether Rhythm’s new drug application (NDA) is acceptable for filing…

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