Shares of small-cap biotech AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) are crashing Wednesday morning.
AMAG said the FDA's Bone and Reproductive and Urologic Advisory Committee, which met to discuss the PROLONG confirmatory trial for its Makena, voted 9-7 in favor of pulling the product out of the market.
Makena is hydroxyprogesterone caproate injection approved in 2011 to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth. Subsequently, in February 2018, AMAG received FDA nod for Makena subcutaneous auto-injector drug-device combo for reducing the risk of preterm birth in certain at-risk women,
While nine members voted for the withdrawal of approval, seven voted to leave the product on the market under accelerated approval and require a new confirmatory trial.
AMAG noted that five of the six clinicians on the committee expressed concerns that the withdrawal would leave providers with no safe treatment options for pregnant women.
The FDA could consider the panel recommendation, but is not bound to necessarily go with it.
Specter Of Revenue Hit Looms
For the second quarter ended June 30, Makena subcutaneous auto injector fetched revenues of $41 million or roughly 53% of the total revenues. The company's market share grew 9% points quarter-over-quarter in the second quarter to 63%.
"We are disappointed with the nearly split vote on this key question and we are committed to working with the FDA to identify feasible ways to generate additional efficacy data on Makena while retaining current access to the therapy for at-risk pregnant women," Julie Krop, chief medical officer at AMAG said in a statement.
The PROLONG trial, which was conducted as part of the FDA approval commitment, studied 1,700 pregnant women.
AMAG shares were down 25% to $9.98 at time of publication.
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