Octreotide capsules, an oral drug, are indicated for the maintenance therapy of adult patients with acromegaly.
The agency has assigned a Prescription Drug User Fee Act (PDUFA) date by the end of August, which is the target date for the FDA to complete its review of the NDA..
Chiasma chief executive officer Mark Leuchtenberger said: "We are very pleased that the FDA has accepted this filing for our octreotide capsules product candidate, as well as conditionally accepted the proposed trade name of Mycapssa.
"Based on our Phase 3 results and feedback from patients and healthcare providers, we believe that octreotide capsules have the potential to be an important treatment option for adults living with acromegaly, whose current standard treatment consists of lifelong and painful injections with an array of undesirable side effects."
The NDA is based on data from a Phase III trial that evaluated patients for biochemical and symptomatic disease control over a period of up to 13 months following treatment with octreotide capsules, comprised of a 7-month core treatment phase and an optional 6-month extension phase.
About 65% of patients in the modified intent to treat (mITT) population who received octreotide capsules twice-a-day were classified as responders, as measured by circulating concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) at the end of the 7-month core treatment period, the primary endpoint of the trial.
While 62% of patients in the mITT population were classified as responders at the end of the 6-month extension phase.
If approved, octreotide capsules would be the first oral somatostatin analog approved for the treatment of acromegaly.