US FDA approves KV Thera/Ther-Rx' Makena, first drug to reduce risk of preterm birth in at-risk pregnant women

The US Food and Drug Administration on Friday approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth. This is the first and only product cleared for this indication in the USA, and Makena will be marketed by KV Pharmaceutical’s (NYSE: KVa/KVb) branded drug unit Ther-Rx. According to the FDA, it is manufactured by Baxter Pharmaceutical Solutions.

The news was a terrific boost for KV, which saw its shares rise as high as $4..22 on Friday before closing the day up 153% at $3.88 in heavy trading on on the New York Stock Exchange.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth. The FDA approved Makena under the agency's accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (here, reducing the risk of delivery before 37 weeks of pregnancy) that is reasonably likely to predict a clinical benefit.