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Gestiva in a Catch-22

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA says it will not approve KV Pharmaceuticals' pregnancy drug Gestiva until the firm makes revisions to a post-approval trial protocol and meets an enrollment goal for that trial. The agency and KV had agreed to FDA-suggested revisions to the protocol, but added other conditions for approval, including that the trial must have a specified portion of study subjects enrolled prior to final approval. The firm announced receipt of FDA's "complete response" letter Jan. 26. But KV is running out of money and isn't due to get funds from Hologic, its marketing partner for Gestiva, until the drug is approved. On Feb. 9 KV said it would reduce its workforce by 700. Gestiva (alpha hydroxyprogesterone caproate) is intended to prevent preterm birth in at-risk women
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