You are here
FDA Says “No” to Octreotide (Mycapssa) for Maintenance Treatment of Acromegaly
Chiasma, Inc., has released updated information about a complete response letter (CRL) that the company received from the FDA regarding its new drug application (NDA) for octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly. The FDA issues CRLs to indicate that an application is not ready for approval in its present form.
The FDA advised Chiasma that it did not believe the company’s application had provided substantial evidence of efficacy to warrant approval. The FDA advised Chiasma that it would need to conduct another clinical trial to overcome this deficiency.
The FDA expressed concerns regarding certain aspects of the company’s single-arm, open-label, phase 3 study and strongly recommended that the company conduct a randomized, double-blind, controlled trial that enrolls patients in the United States and is sufficiently long to ensure that the control of disease activity is stable at the time point selected for the primary efficacy assessment. In addition, the FDA advised that, during a recent site inspection, certain deficiencies were conveyed to the representative of one of Chiasma’s suppliers that would need to be resolved before octreotide could be approved. The FDA did not note any safety concerns related to the drug in its letter.
If it had been approved, octreotide would have been the first oral somatostatin analog indicated for adults with acromegaly. Octreotide capsules were granted an orphan drug designation in the U.S. for the potential treatment of the disease.
Source: Chiasma; April 18, 2016.