Chiasma: FDA Accepts For Filing NDA For Marketing, Sale Of Octreotide Capsules

(RTTNews) - Chiasma, Inc. (CHMA), a late-stage biopharmaceutical company, Monday said the U.S. Food and Drug Administration has accepted for filing the company's New Drug Application for the marketing and sale of octreotide capsules, an oral drug proposed for the maintenance therapy of adult patients with acromegaly.

Acromegaly develops when a benign tumor of the pituitary gland produces too much growth hormone, ultimately leading to significant health problems and early death if untreated.

The FDA is expected to inform the company of the Prescription Drug User Fee Act date by the end of August. The PDUFA date is the target date for the FDA to complete its review of the NDA.

The application, submitted on June 15, is supported by a multicenter Phase 3 study 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.

If approved, octreotide capsules would be the first oral somatostatin analog approved for acromegaly. They have been granted orphan designation in the U.S. and the EU for the treatment of acromegaly.