All articles tagged with #makena
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The FDA has withdrawn its approval for Makena, a drug intended to prevent premature births, after studies showed it wasn't effective.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The FDA has withdrawn its approval of Makena, the only drug approved more than a decade ago to reduce the risk of preterm birth, stating that it is not effective and that the benefits of taking it do not outweigh the risk. The maker of the drug, Covis Pharma, said it was moving to withdraw the medication from the market after an FDA panel said it is not effective. The FDA recognizes that there is a supply of product that has already been distributed and said patients who have questions should talk to their healthcare provider.
The FDA has revoked the approval of Makena, the only drug cleared to reduce the risk of preterm birth, due to a lack of evidence that it works. The decision marks the end of a long-running saga involving the drug, which was approved in 2011. Preterm birth is a serious condition that disproportionately affects Black women and women of color, and about 1 in 10 babies in the US are born prematurely. The cause of preterm birth is unknown, and there are currently no effective treatments for the condition.
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 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. The medication 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 can cause side effects, including blood clots, depression and allergic reactions. The FDA expedited Makena's approval in 2011 based on a small study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term.
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.
The FDA has withdrawn approval of Makena, a drug used to reduce the risk of preterm birth in women with a history of spontaneous preterm birth, due to a lack of clinical benefit. The drug was approved under the accelerated approval pathway in 2011, but a post-marketing confirmatory study did not verify clinical benefit. The FDA recognizes the need for effective treatments for preterm birth, which has a disparate impact on communities of color, especially Black women. Patients with questions should talk to their healthcare provider.