Unproven Birth Drug ‘Makena’ To Be Withdrawn From The US Market
(CTN NEWS) – After regulators indicated they would proceed with a long-delayed campaign to remove the product Makena from the market.
The manufacturer of an unproven medication meant to prevent preterm births has announced that it will voluntarily remove the medicine from the United States.
Makena is a synthetic progesterone hormone required to sustain a pregnancy. It is the only medication for lowering the risk of premature birth with FDA approval.
Around four years after Makena failed to demonstrate a benefit in assisting mothers to bring pregnancies to term, Covis Pharma announced its removal on Tuesday.
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 injectable drug symbolizes the FDA’s struggles to recall a drug when the maker won’t do so voluntarily.
It’s still unclear when the medicine will be removed.
Birth Drug ‘Makena’ To Be Withdrawn
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.
The business claims that the FDA made it plain that it will continue to remove the medicine under its own terms.
The agency’s drug regulators suggested making the withdrawal “immediately effective” in a separate file on Wednesday.
The agency stated no evidence of “harm from stopping Makena, such as withdrawal signs or symptoms.”
Robert Califf, the FDA commissioner, is anticipated to decide the drug’s future shortly after consulting with the agency’s top scientist.
Covis To Collaborate With FDA
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.
Such hearings are uncommon and only occur when a manufacturer refuses early FDA demands to halt the sale of its product.
In a statement, Raghav Chari, chief information officer of Covis, stated that the company “stands by Makena’s attractive benefit-risk profile, particularly its efficacy in women at highest risk of preterm birth.”
However, the company is looking to voluntarily withdraw the product and is collaborating with the FDA to implement an orderly wind-down.
Despite differences of opinion over the timeline, the business noted that it “remains ready to work amicably with the agency” to remove the drug.
10% of births in the US occur before 37 weeks, which increases the likelihood that the child will experience major health issues or perhaps pass away. The issue affects African women more frequently.
Based on a limited trial of women with a history of early deliveries, the FDA approved Makena 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 hypothesised reduction in preterm deliveries nor the improvement in newborn health.
Despite such findings, reproductive experts, including members of the American College of Obstetricians and Gynecologists, have pushed for maintaining the drug’s availability until additional research is conducted.
The organization declared on Wednesday that its present policies would continue to be in place until FDA made a final determination.
For the sake of the patients’ and their family’s health and well-being, the group emphasized the need to find further, successful strategies to stop recurring preterm birth.
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