Makena Vs. Avastin: No Contest When It Came To Withdrawal Process Duration

11 Apr 2023

Approximately 41 months passed from the initial advisory committee meeting in October 2019 on Makena’s potential withdrawal to the 5 April 2023 final decision by FDA's commissioner and chief scientist - more than double the length of the same interval in the accelerated approval withdrawal proceeding involving the breast cancer claim for Genentech's Avastin.

Race car — Avastin sped through the withdrawal process relative to the much-delayed Makena proceeding. • Source: Shutterstock

By whatever starting metric is used, the withdrawal process for Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) was a long one, with the drug removed from the market:

Approximately 41 months passed from the initial advisory committee meeting in October 2019 on Makena’s potential withdrawal to the 5...