U.S. FDA revokes approval of premature birth drug Makena

LOS ANGELES, April 6 (Xinhua) -- The U.S. Food and Drug Administration (FDA) announced on Thursday its final decision to withdraw approval of a drug intended to prevent premature births.

The drug, named Makena, was approved under the accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth, according to the FDA.

Effective Thursday, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce, said the FDA in a 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.

The agency's approval included a requirement that the sponsor conduct a post marketing confirmatory study.

The ensuing confirmatory study did not verify clinical benefit and the FDA's Center for Drug Evaluation and Research proposed withdrawing the drug's approval in 2020.

The sponsor requested a hearing, which was held in October 2022. Following the hearing, the FDA Commissioner and Chief Scientist reviewed the record for this matter, and decided to withdraw approval of Makena and its generic versions.

"It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes -- particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women," said FDA Commissioner Robert M. Califf in a statement.