FDA Considers Withdrawing Makena Approval

AMAG Pharmaceuticals has received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth. The FDA in its letter also notified AMAG that the company has the opportunity to request a hearing on the withdrawal.

AMAG is evaluating its range of potential options. The company has 15 days to respond to the FDA indicating whether AMAG would like to proceed with a hearing. If AMAG does request a hearing, the FDA Commissioner would decide whether to grant AMAG’s request and, if granted, would conduct a hearing and decide whether to withdraw approval following the hearing. This process can take months and during this time Makena and the approved generics of Makena will remain on the market, according to the FDA.

“We disagree with the FDA’s proposal to withdraw Makena without having the opportunity to meet with them to discuss the generation of additional effectiveness data while preserving access for patients to the only FDA approved treatment option for indicated women,” said AMAG CEO Scott Myers. “We are reviewing our options, including the opportunity to request an oral hearing, and will respond to the agency within the allotted time. We continue to expect the transaction with Covis to close in November 2020.”

At this time, Makena’s approval and product label remain unchanged. The product continues to remain available to patients and prescribers.

“I am concerned that withdrawal of Makena, as well as the generic equivalents, would leave vulnerable women with high risk pregnancies without access to a safe medication that physicians have relied upon for years, and has previously been shown to be highly effective when studied by the NICHD in a U.S. only population,” Sean Blackwell M.D., Chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at the McGovern Medical School – UTHealth at Houston. “The PROLONG trial did not re-affirm efficacy, in my opinion, because it did not include enough women at high enough preterm birth risk.  Given the results of the original NICHD trial, removing the ability for physicians and their patients to make a shared-decision on the benefits and risks of the only FDA-approved medication to prevent preterm birth is disappointing.”

Preterm birth is the leading cause of infant morbidity and mortality in the U.S, and a history of spontaneous preterm birth is a substantial risk factor for recurrent preterm birth. Women, particularly those of color, are profoundly impacted by preterm birth, which is associated with the potential for babies born early to experience lifelong complications. There is also increasing recognition that health care outcomes, such as preterm birth, are impacted by social determinants of health.