, though Covis has repeatedly appealed for more time to conduct additional research. 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.
The company said that extended off-ramp would give women who are still receiving the drug time to finish their course of treatment, which involves weekly injections starting after 16 weeks of pregnancy. Covis said it made its proposal to the FDA following an October public meeting at which outside advisers overwhelmingly concluded that Makena hasn’t been shown to work and should have its approval revoked. Despite hours of presentations and debate, the panel was unconvinced by arguments from Covis that the drug could be useful for a subgroup of women.
“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,” said Raghav Chari, Covis' chief information officer, in a statement.
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