The FDA told Chiasma Inc. that they needed to conduct another clinical trial to gather more “sufficient data”.
Despite receiving a complete response letter void of any safety concerns from the FDA earlier this month, Chiasma Inc.’s open-label phase 3 clinical trial wasn’t enough to gain approval for the oral octreotide (Mycapssa). The drug has officially been rejected by the FDA for the maintenance treatment of adults living with the rare disease, acromegaly.
According to the CFR Code of Federal Regulations 21, (PART 314 — APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG) the FDA sent Chiasma Inc. a complete response letter saying there wasn’t enough evidence of the drug’s efficacy provided for approval.
The Pharmacy Times reported on Monday that the FDA had 3 “encouragements” for Chiasma Inc. and the next steps toward an approval:
- They want to see a randomized, double-blind, and controlled trial involving US patients
- They also want said trial to be longer in duration
- They want to set up an end-of-review meeting
You can read Chiasma’s official Press Release to the FDA’s Response Letter earlier this month here, where President and CEO Mark Leuchtenberger said that Chiasma will Proceed with their MPOWERED™ Phase 3 trial. This trial is a comparison study of the safety and efficacy of Mycapssa to monthly analog injections of somatostatin. This study in particular would support a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
“We continue to believe in the potential for Mycapssa to help many patients with this orphan disease, and we intend to work diligently on their behalf to obtain U.S. approval.”
@PatientWorthy to join the conversation about the rejection of octreotide (Mycapssa).