AMAG Pharmaceuticals’ shares fall 21% after failed Makena trial
AMAG Pharmaceuticals’ Makena (hydroxyprogesterone caproate) has failed to meet its co-primary endpoints in a trial of patients with a history of a prior spontaneous singleton preterm delivery. Shares in the US firm fell by as much as 21% on announcement of the news.
The PROLONG trial of 1700 pregnant women showed that the incidence of preterm delivery was 11 percent in the Makena group versus 11.5% for those taking a placebo.
Meanwhile 5.4% of those in the Makena group compared to 5.2% of those in the placebo group met the criteria for the pre-specified neonatal morbidity and mortality composite index. Makena gained FDA approval for the studied indication in 2011.
“After the initiation of the PROLONG trial and the approval of Makena in the U.S., Makena became the standard of care for pregnant women who have had a prior spontaneous preterm birth. This led to a reluctance by U.S. physicians to enroll their patients in a placebo-controlled clinical trial and therefore, the majority of patients in the PROLONG trial were enrolled outside of the U.S., predominantly from Eastern European countries, with very different demographics compared to the Meis trial,” said Julie Krop, M.D., AMAG’s Chief Medical Officer.
“In light of these recent findings and the inconsistencies with prior clinical evidence, we plan to conduct additional sub-group analyses of the PROLONG data, particularly focusing on patients at the highest risk of preterm delivery and the subset of patients enrolled in the U.S. We will work closely with our publications committee to further assess the data, submit the findings to the FDA, and prepare the data for peer reviewed publication.”
“Our committee will be reviewing the trial data in detail and we will be actively involved in the analysis and interpretation of the findings. It is clear that the overall study population of PROLONG is significantly different than those who participated in the NICHD MFMU trial with respect to race, socioeconomic status, and severity of disease. Thus, we need sufficient time to thoughtfully interpret these findings in the context of the prior clinical trials,” Dr Sean Blackwell, Chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at the McGovern Medical School – UTHealth at Houston and Immediate Past President of the Society for Maternal-Fetal Medicine (SMFM) said.
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