The only drug approved in the US to reduce the risk of premature birth will be immediately pulled from the market due to a lack of effectiveness, after manufacturer Covis Pharma Group had pushed for a gradual withdrawal.
(Bloomberg) — The only drug approved in the US to reduce the risk of premature birth will be immediately pulled from the market due to a lack of effectiveness, after manufacturer Covis Pharma Group had pushed for a gradual withdrawal.
“After thoroughly reviewing the record for this matter, we have determined that there is an insufficient demonstration of effectiveness to balance any level of risk.” the Food and Drug Administration, said in a statement. Last month, the agency’s staff recommended immediate withdrawal of Makena and its generic equivalents as the treatment “unnecessarily exposes patients to only risks.”
The action is the latest development in a controversy around drugs like Makena that were cleared via accelerated approval, an expedited regulatory pathway meant to give patients access to experimental drugs based on promising preliminary data. Follow-up studies required to validate those expectations are often delayed, meaning patients may be exposed to questionable treatments — and their risks — for years.
“Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” an FDA spokesperson confirmed in an email.
Covis Pharma didn’t immediately respond to request for comment.
An FDA advisory panel voted in October to recommend retracting approval. Covis, acquired in 2020 by Apollo Global Management, had announced plans in March to withdraw Makena in an “orderly wind-down,” saying that immediate withdrawal would be disruptive to patients.
Read More: Drug to Prevent Preterm Births to Be Pulled from US Market
Thursday’s decision came jointly from FDA Commissioner Robert Califf and chief scientist Namandjé Bumpus.
The officials denied Covis’s request for a slow wind-down, leaving the timing of the withdrawal up to the FDA’s Center for Drug Evaluation and Research, according to the statement. CDER earlier called for an immediate withdrawal of the drug.
Makena won accelerated approval in 2011 but the original maker didn’t complete a subsequent study intended to confirm its benefits until 2019 — eight years after approval. The study found no overall benefit, and the FDA proposed pulling the drug from the market in 2020. However, Covis fought to keep it on the market, and sales continued.
Common adverse reactions associated with Makena include pain and swelling at the injection site, according to the drug’s label, which also warns of risks of depression, fluid retention, decreased glucose tolerance, allergic reactions and clotting disorders.
(Adds FDA comment in fourth paragraph)
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