FDA looks to pull pre-term pregnancy drug Makena

The Food and Drug Administration wants to withdraw Makena, a drug that claims to reduce the risk of pre-term births. The FDA says the drug doesn't work — but the pharmaceutical company that produces it says the FDA's study didn't include enough Black women, who are at a higher risk for preterm birth.

WASHINGTON - The Food and Drug Administration wants to withdraw Makena, a drug that claims to reduce the risk of pre-term births. The FDA says the drug doesn't work — but the pharmaceutical company that produces it says the FDA's study didn't include enough Black women, who are at a higher risk for preterm birth.

Makena was first introduced in 2011 by Covis Pharma. The company touts it as a miracle drug for women at high risk of pre-term pregnancies, and is the only U.S. drug on the market intended to prevent premature births.

The FDA declared the drug ineffective more than two years ago and called for its removal. Results from a study released in 2019 showed the drug neither reduced premature births nor resulted in healthier outcomes for babies while increasing the risk of blood clots, depression, and other side effects in mothers.

"Based on the evidence shown today, Makena is not shown to be effective," said FDA’s drug chief, Dr. Patrizia Cavazzoni, in opening remarks Monday. "Its benefit and risk profile is unfavorable and it should be withdrawn from the market."

But, Covis Pharma says there's evidence to suggest Makena works for Black women, who have historically been at higher risk of maternal complications. Covis argues that Black women are at higher risk for preterm birth, but made up just 7% of women in the international study, compared with 59% in the original U.S. study used for approval. The company wants time to conduct another study in higher-risk patients.

Preterm birth is one of the most costly health issues in the U.S., and Makena is no exception — the drug can cost up to $10,000 for some people. Preterm birth, which happens before 37 weeks of pregnancy, occurs in about 10 percent of all births and affects Black women more than other racial groups in the U.S.

"We believe there is no sound public health reason to deprive" patients and physicians of access to Makena, the company said in an emailed statement.