A drug for pregnant women doesn’t work, according to the FDA. A company is selling it anyway
LOS ANGELES — American babies are at far higher risk of dying before their first birthdays than those in almost any other wealthy country. A big reason for those deaths, more than 21,000 each year, is that too many are born too soon.
For more than a decade, a pharmaceutical company has said it holds the key to helping those infants: a drug called Makena, which is aimed at preventing premature birth.
But the drug doesn't work, according to the Food and Drug Administration.
A recent large study "unequivocally failed to demonstrate" that Makena reduced the risk of preterm birth, agency scientists explained in a 2020 memo. They recommended it be taken off the market.
The company has refused.
Instead, Covis Pharma, a Luxembourg company owned by private equity firm Apollo Global Management Inc., has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births.
Covis dismisses the results of the recent study since it included more white European women than Black Americans. It points to favorable older trials also disputed by the FDA, and it's asking for more time to prove to authorities that Makena works.
The company's continued push to sell the drug, as well as decisions by the nation's top societies of physicians caring for pregnant women to continue to recommend it, has troubled and angered some doctors.
"We keep injecting pregnant women with a synthetic hormone that hasn't been shown to work," said Adam Urato, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Massachusetts.
More than 310,000 women have taken Makena during their pregnancies since 2011 when the FDA rejected concerns of outside experts as well as one of its own scientists and approved the drug.
Among those women is Brittany Horsey, who had just received her weekly Makena injection in 2020 when she went into labor later that day — four weeks too soon.
She had a similar experience with the drug three years before with her second pregnancy. That child came six weeks early.
"It didn't work," said Horsey, 24. But the Baltimore mother still suffered from the side effects. She was hit with migraines and depression soon after starting the shots. The drug's written label lists both as possible complications.
Makena's lack of effectiveness has not reduced what Covis lists as the drug's price — currently $803 per weekly shot, according to GoodRx, which tracks national prices set by drug manufacturers, or about $13,000 for the full course of injections often prescribed during a pregnancy.
And, despite the prescriptions, the rate of preterm births in the U.S. has continued to rise. Federal officials reported in March that 10.23% of the nation's births were preterm in 2019 — the fifth-straight annual rise.
Covis, which took over sales of Makena when it purchased AMAG Pharmaceuticals late last year, declined to make executives available for interviews. In a written statement, it pointed to a recent reanalysis of previous Makena trials that found evidence that the drug worked. The FDA those previous trials and had not changed its finding that
