FDA advisers recommend withdrawing preterm birth drug from market
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The FDA Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted 14-1 to remove a drug indicated for preventing preterm birth from the market due to lack of effectiveness.
The committee said the medication — Makena (hydroxyprogesterone caproate injection; Covis Pharma) — should not remain on the market while a study designed to confirm its effectiveness is ongoing, according to a company press release.
Makena initially became available in 2011 following an accelerated approval from the FDA and is currently the only drug on the U.S. market indicated for use by people who have a history of spontaneous preterm birth.
An FDA advisory committee recommended removing Makena from the market in late 2019.
Recommendations of advisory panels are not binding, although the FDA often follows these suggestions. The medication remains approved until the FDA makes a final decision.
Perspective
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I and many others have worked in this area for many years. One of the aspects was voiced nicely by my colleague at University of South Florida. A woman comes to us saying “I have a history of preterm birth, the baby was in the nursery for 3 months, I’m pregnant again. What can you do?” Other than bedrest, there is not a lot we can do unless there is a specific indication, and that is very sad. We should be able to have a treatment.
When you look at the two studies conducted on this drug, the first study showed benefit, and the second study did not. Many of us have felt that the first study was sufficient to support using the drug. More likely than not, based on this recommendation, it will be withdrawn. That leaves us with nothing [to prevent preterm birth], unless there is an indication such as short cervix or use of cerclage or pessary. On that hand, it is very disappointing; it feels like we are going back to the beginning.
On the positive side, it was clear that people understand that Black and Indigenous folks are all at risk for this problem, and that we need to find something that will help them. A drug may be one aspect, but there are other social determinants that we need to look at as well.
We need to keep working at this, and the companies need to keep working to find a drug.
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Covis Pharma Reports on FDA Advisory Committee Hearing for Makena. https://covispharma.com/index.php/covis-pharma-reports-on-fda-advisory-committee-hearing-for-makena/. Published Oct. 19, 2022. Accessed Oct. 20, 2022.
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