For Physicians. By Physicians.™
For Physicians. By Physicians.™
This FDA has released materials in support of withdrawing approval of Makena (17-OHPC). The FDA documents can be found in ’Learn More – Primary Sources’ below. At the October 17-19 Obstetrics, Reproductive, and Urologic Drugs Advisory Meeting, the committee voted 14 to 1 that that Makena should be removed from the market while awaiting any further confirmatory studies. FDA will take the committee recommendations and make a final decision.
The authors of the PROLONG trial (Progestin’s Role in Optimizing Neonatal Gestation) reported on the use of 17α-hydroxyprogesterone caproate (17-OHPC) for the treatment of preterm birth (PTB)
In this study population, 250 mg 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal/early infant death
On October 29, 2019, the FDA advisory committee recommended that the drug be withdrawn from the market (9 to 7 vote). On October 5, 2020, the Center for Drug Evaluation and Research (CDER) proposed that Makena be withdrawn from the market. At that time, the decision was made to hold further meetings and discussions. Based upon further follow-up, the CDER briefing materials for the Advisory Committee meeting (October 17-19, 2022) states
Makena has not been shown to improve neonatal outcomes from premature birth, is no longer shown to be effective for its approved use, and has known risks
The 1,708-person confirmatory trial designed to verify Makena’s clinical benefit instead failed to show that Makena has any benefit to newborns. Data from this trial, taken together with other evidence, also fail to show that Makena reduces the risk of recurrent preterm birth
For these and other reasons detailed herein, Makena should be withdrawn from the market
Meis Trial
Prolong Trial
Authors’ Conclusion
We assert PROLONG was underpowered, based on substantially lower observed preterm birth rates than anticipated, and therefore was a false-negative study, rather than the Meis trial being a false-positive study
Careful assessment of these two trials is critical as removal of 17α-hydroxyprogesterone caproate from the U.S. marketplace may have substantial effects on public health
Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. (NEJM, 2003)
FDA (October 2020): CDER proposes withdrawal of approval for Makena
FDA Briefing Materials for Withdrawal of Makena Approval (2022)
ACOG: Statement on FDA Committee Recommendation to Withdraw 17p Hydroxyprogesterone Caproate
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