Biotech Stocks Facing FDA Decision In October 2019

AMAG Pharmaceuticals
AMAG Pharmaceuticals

On October 29, 2019, AMAG Pharmaceuticals Inc. (AMAG) will know the FDA panel’s views in allowing Makena, a subcutaneous auto-injector drug-device combination product as a ready-to-administer treatment, to continue in the market.

Makena received accelerated approval from the FDA in 2011 for the prevention of preterm birth in pregnant women. Companies whose drugs are approved under the “accelerated approval pathway” are required to conduct a post- approval confirmatory clinical trial to verify and describe clinical benefit. Only then, will the accelerated approval be converted into a full approval.

In the case of Makena, the completed confirmatory trial, dubbed PROLONG, has not demonstrated a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity.

AMAG developed the Makena auto-injector with its device partner Antares Pharma Inc. (ATRS), which holds issued patents on the auto-injector device and drug-device combination, the last of which expires in 2034.

Sales of Makena in 2018 were $322 million - down from $387 million in 2017. In the first half of 2019, sales of the drug slipped to $62 million from $195 million in the comparable year-ago period.

AMAG closed Friday’s (Sep.27, 2019) trading at $12.10, up 0.58%.