Mycapssa octreotide regulatory update

FDA issued a complete response letter to Chiasma for an NDA for Mycapssa octreotide as a maintenance treatment for adults with acromegaly. Chiasma said FDA thinks the NDA had not provided “substantial evidence of efficacy to warrant approval” and expressed concern about the single-arm, open-label Phase III trial that supported the submission. Chiasma said FDA “strongly recommended” a double-blind, controlled trial that enrolls U.S. patients and is long enough to ensure that control of disease activity is stable when the primary endpoint is assessed. FDA also said “deficiencies” at a company supplier would need to be resolved before approval, according to Chiasma.

Chiasma plans to request an end-of-review meeting with FDA before forming an action plan. Last month, Chiasma started the open-label, international Phase III MPOWERED trial comparing Mycapssa vs. monthly injectable somatostatin analogs. That trial is designed to support an EU submission of Mycapssa. ...