Maker of unproven birth drug Makena to pull from US market

, 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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Maker of preterm birth drug Makena to withdraw it from market | CNNThe maker of the drug Makena, which was approved more than a decade ago to reduce the risk of preterm birth, said Tuesday that it is moving to withdraw the medication from the market after a US Food and Administration panel said it is not effective. Now if they would have only done that with the Covid vaccines. Think of the lives they would have saved. The vaccine has also proven not to work against c19 but your not pulling that. Wonder why?
Fonte: CNN - 🏆 4. / 95 Consulte Mais informação »

Drug to Prevent Preterm Births to Be Pulled From MarketThe maker of Makena said it will stop selling the drug to prevent preterm births after a study couldn’t confirm the medicine worked Wtf are these things let out before we know this. Jesus f----- Christ Good, do aducanumab next. How did it get approved in the first place?
Fonte: WSJ - 🏆 98. / 63 Consulte Mais informação »