FDA Withdrawal of Approval for Makena
StayWell Insurance | April 2023 | Maite, GU
The FDA has announced their decision to withdraw approval of Makena — a drug that was previously approved under the accelerated approval pathway. The drug is meant to reduce the risk of pre-term birth in women pregnant with one baby who have a history of spontaneous pre-term birth. This decision issued jointly by the FDA Commissioner and Chief Scientist went into effect on April 6th, 2023 and includes Makena and its generics. Consumers should know that these drugs can no longer be lawfully be distributed in interstate commerce.
In 2011, Makena was approved under the accelerated approval pathway based on the demonstration of its sponsor that the effect of the drug on intermediate clinical endpoint that was reasonably like to provide clinical benefit. This process of accelerated approval included such requirements as a post marketing confirmatory study which ultimately could not verify clinical benefit which led the FDA’s proposed withdrawal of the drug’s approval in 2020. After a requested hearing on behalf of the drug’s sponsor held in October 2022 the FDA Commissioner and Chief Scientist, after fully reviewing the results of the hearing and other requirements for accelerated approval decided to withdraw the approval of Makena and its generics.
Consumers should know that the approval of Makena and its generics are because the drugs are no longer shown to be effective, and the benefits do not outweigh the risks for the indication which they were approved.
For additional information, see Makena Information on FDA.gov.
For more information, please review the press release from the FDA.
If you are a StayWell member currently prescribed Makena or its generics, or would like more information please also feel free to reach out to the StayWell Customer Care Department via email at [email protected] or by phone at (671) 477-5091.