AMAG Pharmaceuticals (AMAG) announced that the results of the PROLONG trial were published online in the American Journal of Perinatology.
AMAG Pharmaceuticals, Inc. (AMAG) announced that the results of PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) were published online in the American Journal of Perinatology. PROLONG was a randomized, double-blind, placebo-controlled clinical trial evaluating 17-OHPC (17-α-hydroxyprogesterone caproate or Makena®) in patients with a history of a prior spontaneous singleton preterm delivery. The PROLONG trial was conducted as part of an approval commitment under the Food & Drug Administration’s (FDA) “Subpart H” accelerated approval process.
As previously announced, the PROLONG trial did not meet the two pre-specified co-primary endpoints of a reduction of preterm birth and a reduction in the neonatal morbidity and mortality index, in contrast to the original Meis trial results published in the New England Journal of Medicine.
PROLONG reaffirmed that the 17-OHPC safety profile is comparable to placebo, the company said.
Makena is a progestin indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth.
Makena was approved by the FDA in February 2011 and was granted orphan drug exclusivity through February 3, 2018. In February of 2018, AMAG introduced the prefilled Makena auto-injector containing a short, thin, non-visible needle for subcutaneous use, offering patients and providers a new administration option.
The FDA will hold a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee on October 29 to “better understand and interpret the PROLONG trial data,” AMAG added.
Piper Jaffray analyst Christoper Raymond said the briefing documents posted this morning ahead of Tuesday’s advisory committee meeting to discuss Makena’s failed confirmatory PROLONG trial “leave the door open” for the continued marketing of the drug.
Draft questions propose pursuing withdrawal of Makena’s approval, leaving Makena on the market but requiring a new confirmatory trial, or leaving it on the market without a new confirmatory trial and he thinks it appears that the FDA “is leaning toward the latter two options.”
However, he also thinks that the detailed PROLONG data that have now been provided for the first time “make a strong argument for the drug’s withdrawal,” Raymond tells investors.
The analyst sees the full PROLONG data having “some chilling effect” on overall use whether the FDA pulls the drug or not and he keeps a Neutral rating on Amag Pharmaceuticals shares.
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