Shares in K-V Pharmaceutical nearly tripled after the FDA approved Makena (hydroxyprogesterone caproate) to reduce the risk of preterm delivery before 37 weeks of pregnancy, in women with a history of spontaneous preterm birth. Sandra Kweder, deputy director of the FDA's office of new drugs, noted that Makena "is the first drug approved by the FDA that is indicated to specifically reduce this risk," which is seen as "a significant public health issue" in the US.
The drug, previously known as Gestiva, was developed by Hologic, but under an existing asset agreement, global rights are scheduled to be transferred to K-V Pharmaceutical by February 11.
The US regulator noted that approval of Makena was based on a study involving 463 women aged 16 to 43 years of age who were pregnant with a single foetus and had a previous spontaneous preterm birth. Results of the study showed that among those treated with Makena, 37 percent gave birth before 37 weeks, compared to 55 percent in the control group.
Makena was cleared under the agency's accelerated approval scheme, and an international trial is ongoing to see it there are improvements in the outcome of babies born to women who receive Makena, while a similar follow-up study involving between 580 and 750 infants is expected to be completed in 2018. The therapy is not intended for use in women with multiple gestations or other risk factors for preterm birth, according to the regulator.
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