FDA issues Complete Response Letter relating to Mycapssa (octreotide) for maintenance treatment of acromegaly- Chiasma

Chiasma has announced that it received a Complete Response Letter (CRL) from the FDA regarding the company’s New Drug Application for Mycapssa (octreotide) capsules for the maintenance treatment of US adult patients with acromegaly. The FDA issues CRLs to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.

Upon completion of its review, the FDA advised Chiasma that the Agency did not believe the company’s application had provided substantial evidence of efficacy to warrant approval, and advised Chiasma that it would need to conduct another clinical trial in order to overcome this deficiency. The FDA expressed concerns regarding certain aspects of the company’s single-arm, open-label Phase III clinical trial and strongly recommended that the company conduct a randomized, double-blind and controlled trial that enrolls patients from the United States and be of sufficiently long duration to ensure that 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 approval. The FDA did not note any safety concerns related to Mycapssa in its letter.

Comment: A former collaboration for Mycapssa with Roche was cancelled.

Comment: Chiasma will continue with its pre-planned Phase III trial in the hope the EMA will give the drug a European approval.