EU Regulator Pulls Approval for Preterm Labor Drug One Year After FDA

Pregnant woman in distress/iStock, Motortion

Pictured: Pregnant woman sitting in a chair in distress/iStock, Motortion

The European Medicines Agency on Friday recommended withdrawing approval for a drug used to prolong gestation due to the lack of efficacy and a “possible but unconfirmed” risk of cancer. 

Recent studies showed compared to placebo, medicines containing 17-hydroxyprogesterone caproate (17-OHPC) did not decrease rates of preterm birth, according to the European Medicines Agency (EMA). In addition, a review from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concluded a possible risk of cancer to those exposed to the drug in the womb.  

“In view of the concern raised by the possible risk of cancer in people exposed to 17-OPHC in the womb, together with the data on the effectiveness of 17-OHPC in its authorized uses, the PRAC considered that the benefits of 17-OHPC do not outweigh its risks in any authorized use,” according to the EMA, which recommended the “suspension of the marketing authorizations for these medicines.” 

While the EMA’s announcement states that alternative treatments are available for pregnancy at risk of preterm birth, no other drug is currently approved specifically for the indication. Commonly used treatments include progesterone or tocolytics to slow contractions while corticosteroids speed up lung development before delivery.  

“In some EU countries, 17-OHPC medicines are authorized as injections to prevent pregnancy loss or premature birth in pregnant women. They are also authorized for the treatment of various gynecological and fertility disorders,” the EMA noted. 

In April 2023, the FDA pulled its approval for Covis Pharma’s preterm birth prevention drug Makena because it was not deemed effective. At the time, the injection had been available in the U.S. for 12 years. 

Preterm birth is one of the leading causes for neonatal mortality, accounting for around 7.3% of all live births in Europe and are rising in the U.S., averaging 8.67% in 2022. 

In January 2024, the FDA and Duke Margolis Center for Health Policy brought together a group of experts in maternal and fetal health to discuss the concerning lack of innovation in drug development to prevent spontaneous birth.  

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn. 

Back to news