In October 2022, an FDA advisory committee met for two and a half days to discuss the drug’s efficacy after a 2019 trial of 1,000 women found the drug did not reduce the risk of a preterm birth. All 15 members agreed the trial showed Makena had no clinical benefit, and nearly all recommended that the FDA yank its approval.
Before the FDA could issue a decision, Covis Pharma said March 7 it wants to work with the agency to enact a wind-down period so patients who take the drug can adjust.
“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,” Covis Chief Innovation Officer Raghav Chari, PhD, said.
If the FDA agrees, people who currently take Makena could finish their 21-week treatment course, according to the Journal.
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