All articles tagged with #covis pharma
The FDA is withdrawing its approval of Makena, the only drug on the market for reducing the risk of preterm birth in pregnant women, due to a lack of effectiveness demonstrated by the treatment. Covis Pharma, the maker of Makena, will make a last-ditch effort to keep its medication on the market in October 2022. There are currently no approved treatments for preterm birth.
The FDA has withdrawn its approval for Makena, a drug intended to prevent premature births, after studies showed it wasn't effective. Makena and its generics can no longer be distributed in interstate commerce. Preterm birth rates are highest for Black infants compared to other racial and ethnic groups, and there is no other approved treatment for preventing preterm birth. Covis Pharma, the drugmaker, had previously said it would pull Makena voluntarily, but the FDA rejected that proposal.
The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, from the US market after data showed it doesn't help pregnant women. Swiss drugmaker Covis Pharma had tried to keep the drug on the market while conducting additional studies, but the FDA rejected this proposal. Makena was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The FDA expedited Makena's approval in 2011 based on a small study, but a larger study completed in 2018 showed the drug neither reduced premature births nor resulted in healthier outcomes for babies.
The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, after data showed it doesn't help pregnant women. Swiss drugmaker Covis Pharma had repeatedly tried to keep the drug on the market while conducting additional studies, but the FDA rejected this proposal. Makena was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy.
The FDA has ordered Covis Pharma to immediately withdraw its preterm birth drug Makena from the market, following a failed confirmatory trial and a 14-1 vote by an FDA advisory committee to pull the drug. Covis Pharma had previously expressed willingness to withdraw the drug and had sought a wind-down period. The FDA has now stated that Makena and its generics are no longer approved and cannot be distributed in interstate commerce.