HQ Team
April 7, 2023: The FDA has withdrawn Netherland-based Covis Pharma’s drug meant to cut preterm birth as it failed to prove its benefits in clinical trials.
The US Food and Drug Administration stated that the final decision to withdraw approval of Makena was taken after a confirmatory study did not verify clinical benefit.
The FDA’s Center for Drug Evaluation and Research planned to withdraw the drug’s approval in 2020. Covis requested a hearing, which was held in October 2022.
Following the hearing, the FDA Commissioner and Chief Scientist reviewed the record, and based on that review, the regulatory body has decided to withdraw approval of Makena and generic versions of Makena, according to an FDA statement.
The FDA approved Makena under the accelerated approval pathway in 2011 based “on a determination that the sponsor” had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit.
Lack of treatment
“This approval was based on a trial that showed the drug reduced deliveries before 37 weeks of pregnancy, an intermediate clinical endpoint that FDA determined was reasonably likely to predict clinical benefit to the newborn,” according to a separate FDA statement.
The FDA’s 2011 decision to approve Makena also considered, among other things, the significant public health impact of newborns born prematurely, the lack of approved treatments for preventing preterm birth, and the potential benefits of early patient access to this treatment.
Due to Makena’s approval, the sponsor was required to conduct a confirmatory clinical trial to verify and describe the predicted clinical benefit to newborns.
“In light of all of the evidence available today, including the results of the confirmatory trial, as well as other information concerning Makena, this drug is no longer shown to be effective,” at reducing the risk of preterm birth in women.
Makena was approved to reduce the risk of preterm birth in pregnant women with one baby and a history of spontaneous preterm birth.
“Tragically, the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes,” said FDA Commissioner Robert M. Califf.
Disparate impact
The failure assumes significance “particularly because this serious condition has a disparate impact on communities of color, especially Black women.”
“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”
The FDA stated that while the approvals of Makena and its generics have been withdrawn, the agency recognizes that a supply of products has already been distributed.
“Patients who have questions should talk to their healthcare provider.” Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective, and the benefits do not outweigh the risks for the indication for which they were approved.
FDA Chief Scientist Namandje Bumpus said: “We acknowledge at the outset the serious problems of preterm birth with respect to maternal and neonatal health and the contribution of institutional forces that have led to health disparities, including preterm birth, among Black women.”
“Nothing in this opinion today is intended to minimize these concerns – to the contrary, we hope that this decision will help galvanize further research.”
Covis Pharma is headquartered in Baarn, Netherlands, with branch operations in Zug, Switzerland. It is a global speciality pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses.
