Chiasma Inc. said it resubmitted a new drug application for Mycapssa in the U.S.
The Waltham, Mass.-based biopharmaceutical company is seeking the U.S. Food and Drug Administration's approval to market Mycapssa as a maintenance treatment for adults with acromegaly, a hormonal disorder that causes an increase in the size of bones of the hands, feet and face. Maintenance therapy is an add-on treatment meant to bolster the main therapy.
Chiasma said in a Jan. 10 press release that its application was backed by positive data from a phase 3 trial, dubbed Chiasma Optimal.
The company said it expects a six-month review of the filing and expects a decision by the FDA by mid-year and hopes to bring the product to the market during the fourth quarter of 2020.
Chiasma also expects to report results from an international phase 3 trial of Mycapssa — called Mpowered — to support the drug's approval in the EU.