The manufacturer of Makena, an unproven medicine meant to prevent premature births, says it will withdraw the product voluntarily from the US market after regulators announced plans to proceed with a long-delayed campaign to remove it from the market.
The maker of an unproven drug used to prevent premature births has stated that it will withdraw the product voluntarily from the US market after regulators announced preparations to launch a long-delayed campaign to remove it from the market.
Premature Birth Drug Makena Pulled Out
The Food and Drug Administration has been working to take the medication off the market ever then, despite Covis’s repeated requests for more time to carry out additional research.
The FDA’s struggles to recall a drug when the maker won’t do so voluntarily have been symbolized by the injectable drug.
In fact, it’s still unclear when the medicine will be removed. Covis, a Swiss company, claimed in a press release that FDA officials turned down its request to gradually reduce medicine use over several months.
The medicine is administered by weekly injections beginning after 16 weeks of pregnancy, and the business claimed that the longer off-ramp will enable women who are still getting time to complete their course of therapy. Covis is still promoting Makena for the time being.
“There might be some misunderstanding regarding Makena’s present situation. Patients and prescribers can still get Makena, “According to the company’s website.
According to the firm, the FDA made it plain that it will carry on with its internal procedure to compel the drug’s removal on its own terms. Robert Califf, the FDA commissioner, is anticipated to make a decision regarding the drug’s future shortly after consulting with the agency’s top scientist.
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Unproven Result
Robert Califf, the FDA commissioner, is anticipated to make a decision regarding the drug’s future shortly after consulting with the agency’s top scientist.
Following a public meeting in October when it was unanimously decided that Makena had not been demonstrated to work and that its approval should be canceled, Covis made its application to the FDA. Despite hours of presentations and discussion, the panel was not persuaded by Covis’s claims that the medicine may be helpful for a group of women in particular.
Such hearings are incredibly uncommon and only take place when a manufacturer refuses early FDA demands to halt the sale of its product.
In the US, 10% of deliveries occur before 37 weeks, increasing the likelihood that the child would experience major health issues or perhaps pass away. The issue affects African women more frequently.
Based on a limited trial of women having a history of early deliveries, the FDA gave Makena expedited approval in 2011.
A lengthier follow-up research was required to confirm whether the medicine gave newborns healthier outcomes before the accelerated approval was granted.
The 1,700-patient international study’s 2019 findings revealed neither the drug’s initial hypothesized reduction in preterm deliveries nor the improvement in newborn health.
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