The Food and Drug Administration (FDA) had a hearing on October 19, 2022 on the Center for Drug Evaluation and Research’s (CDER) proposal to withdraw FDA approval for 17p hydroxyprogesterone Caproate injection, 17-OHPC Makena), 250 milligrams per milliliter, once weekly for its approved indication to reduce the risk of preterm birth in singleton pregnancies, in those with a history of previous preterm birth (FDA, 2022a). In the hearing the Advisory Committee members voted that the findings from Trial 003 [PROLONG Trial]  did not verify the clinical benefit of Makena on neonatal morbidity and mortality from complications of preterm birth; the available evidence did not demonstrate that Makena is effective for its approved indication of reducing the risk of singleton preterm birth in women who have a prior history of singleton preterm birth; and the FDA should NOT allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted (FDA, 2022b; FDA, 2022c).  The FDA commissioner will now review the Advisory Committees recommendations and either accept or reject them. In the meantime, Makena will remain on the market and ACOG’s guidance for the Prediction and Prevention of Spontaneous Preterm Birth will remain in effect (ACOG, 2022). We will provide an update once the FDA commissioner has made a final decision.

 

References and Resources

Food and Drug Administration. (2022a). Makena (hydroxyprogesterone caproate injection) Information. (https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information

Food and Drug Administration. (2022b). UPDATED INFORMATION: October 17 – 19, 2022: Hearing Announcement involving the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee. https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-information-october-17-19-2022-hearing-announcement-involving-obstetrics-reproductive-and

Food and Drug Administration. (2022c). Makena® (hydroxyprogesterone caproate injection) October 18, 2022 Hearing with Respect to CDER’s Proposal to Withdraw Approval. https://www.fda.gov/media/162303/download

Society of Maternal Fetal Medicine (SMFM), 2022. Statement on FDA hearing regarding Makena. https://myemail.constantcontact.com/This-Week-s-FDA-Hearing.html?soid=1101452091407&aid=VYof9qx2p14

American College of Obstetrics and Gynecology (ACOG), 2022. ACOG Statement on FDA Committee Recommendations to Withdraw 17p Hydroxyprogesterone Caproate. https://www.acog.org/news/news-releases/2022/10/statement-on-fda-committee-recommendation-to-withdraw-17p-hydroxyprogesterone-caproate