FDA Finally Gets Its Way on Drug It Wanted Pulled

The number of drugs available to US women who've had a spontaneous preterm birth and are trying to prevent another once again stands at zero. Makena had been the sole drug on the market and was used by about 350,000 women over the last 10 years, but maker Covis Pharma Group on Tuesday announced it was pulling it. Covis' move was a voluntary one, but one in which the maker finally bowed to FDA advisers who in October unanimously found that a study showed the drug didn't actually benefit mothers or babies.

• Context. "Makena had been cited by critics as a flawed example of the FDA's accelerated drug approval program because the agency’s original green light for sale was based on indications that the drug would be effective," per the New York Times. That program can bestow quick approval on drugs that are shown to have promise in treating serious medical needs that lack other treatment options.
• Context II. "The injectable drug has become a symbol for the challenges the FDA faces to withdraw a medication when the manufacturer won't do so voluntarily," per the AP.

• Timeline. STAT in 2019 reported that Makena received FDA approval based on a single clinical trial, a study that Dr. Adam Urato wrote was studded with problems, including that the placebo group was more high-risk than the one that received Makena. The FDA's sped-up approval meant a second trial had to be conducted. The March 2019 results spurred the FDA to look into having Makena pulled; Covis repeatedly lobbied for more time to complete further research.
• Covis' view. "While we stand by Makena's favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down," the company says, per the AP.
• Timeline II. What Covis has pitched to the FDA in terms of that wind-down—letting current patients continue to receive their weekly injection of the drug and using up the inventory that remains—hasn't gotten the green light, per Covis. The process the drugmaker envisions would take more than six months.

(More pregnancy stories.)