Dear SMFM Members:
 
This week, the Food and Drug Administration (FDA) held a hearing regarding the proposal to withdraw accelerated approval of Makena (17-alpha hydroxyprogesterone caproate, 17-OHPC) for the prevention of spontaneous recurrent preterm birth.
 
A number of individual MFM physicians, representing their own views and other organizations, participated in the hearing. Several MFMs served on the Advisory Committee, which had the opportunity to vote on key questions related to Makena’s effectiveness and whether the FDA should allow the drug to remain on the market. Specific questions that were voted on, include:
 
  1. Do the findings from Trial 003 [PROLONG Trial] verify the clinical benefit of Makena on neonatal morbidity and mortality from complications of preterm birth? All the Advisory Committee members voted no.
  2. Does the available evidence demonstrate that Makena is effective for its approved indication of reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth? The majority of the Advisory Committee voted no.
  3. Considering your responses to the previous questions both in the discussions and votes, should FDA allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted? The majority of the Advisory Committee voted no.
 
It is our understanding that the FDA Commissioner must now accept or reject the above recommendations of the Advisory Committee. At this time, Makena will remain on the market and will be available to patients who may want it. Once the FDA Commissioner acts, we will communicate that decision with you.
 
In the interim, the SMFM Publications Committee will convene to review existing clinical guidance on the prevention of recurrent spontaneous preterm birth. If you have any questions, please contact Hannah Lange at [email protected].
 
Joanne Stone, MD, MS
President, SMFM
 
Jeffrey Kuller, MD
Chair, SMFM Publications Committee