AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) announced today that it has formally requested a public hearing in response to the U.S. Food and Drug Administration’s (FDA) proposal to withdraw its approval of Makena®, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth. Makena was approved in 2011, based on the landmark NICHD MFMU trial by Meis et al. A second, FDA-required trial (PROLONG) predominantly enrolled women outside of the U.S., in countries with markedly lower rates of preterm birth. The PROLONG trial did not show a difference between treatment and vehicle arms with respect to preterm birth or neonatal outcome. However, maternal and fetal safety was re-affirmed.
Today’s hearing request will be followed by a submission of supporting documentation to the FDA. That submission will provide further detail on the company’s reasoning for a hearing, recognizing clinicians’ decade-long use of this treatment and the public health implications of withdrawing its approval. At this time, it is important to note that Makena remains approved and available and the product label remains unchanged.
“We believe it is in the best interest of these high-risk pregnant patients to allow their obstetrical provider to determine whether to use Makena, following the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) guidelines, as well as their own long-standing clinical experience. The continued widening of maternal and infant health disparities among minority and disadvantaged communities, and the potential return to compounded versions of Makena are concerning,” said AMAG CEO Scott Myers. “We remain committed to preserving access to the FDA-approved therapy, as there are no other evidence-based options for these vulnerable patients.”
AMAG submitted a proposal earlier this year to the FDA, requesting to meet and discuss two studies intended to define the patient population who would most benefit from therapy: a retrospective study using real world evidence, and a prospective, primary data collection study. FDA declined the request to meet, stating it was premature. AMAG announced in August that it was beginning the first part of the retrospective study.
Covis Pharma has entered into a transaction to acquire AMAG, which is subject to customary closing conditions including the tender offering and is expected to close in November.
Commenting on AMAG’s hearing request, Covis Pharma CEO Michael Porter said, “We support the efforts by AMAG to preserve patient access to this important treatment option. AMAG and Covis believe in Makena’s efficacy for those at risk for recurrent preterm birth, which are often vulnerable patient groups. We respectfully believe that further study is necessary before precipitously withdrawing the product from the market and are prepared to help formulate and implement appropriate study parameters for additional review of its efficacy.”
ACOG issued a statement in response to FDA’s proposed withdrawal, noting that the need for an effective preterm birth treatment is great. As ACOG further recognized, Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition. ACOG states that their treatment recommendations remain unchanged at this time.