Approval was sought for octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.
The FDA has rejected Chiasma Inc’s octreotide (Mycapssa) capsules for the maintenance treatment of adults with acromegaly.
Earlier this month, Chiasma received a complete response letter citing that the application was not ready for approval in its present form.
“We are surprised, disappointed, and respectfully disagree with the FDA’s decision,” said Mark Leuchtenberger, president and CEO of Chiasma, in a press release. “The FDA has encouraged us to request an end-of-review meeting with the agency to discuss the path forward, and we will do so.”
The FDA told Chiasma that it had not provided enough evidence of the drug’s efficacy to warrant an approval and advised that the company conduct an additional clinical trial to collect sufficient data.
The FDA received data from a single-arm, open-label phase 3 clinical trial, but the administration would like to see a randomized, double-blind, and controlled trial involving US patients. The FDA also asked that the trial be long enough to show that the control of the disease is stable for the primary efficacy assessment.
In addition, deficiencies were noted during a site inspection, and one of Chiasma’s suppliers was notified of this.
No safety concerns were listed in the FDA’s complete response letter.
“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 US approval,” Leuchtenberger said in the press release. “In the meantime, we are proceeding with our recently initiated MPOWERED phase 3 trial comparing the safety and efficacy of Mycapssa with monthly somatostatin analog injections to support a potential marketing authorization application with the European Medicines Agency.”