Shares of K-V Pharmaceuticals (KV.A) continued to trade higher Friday morning a day after a doctors’ group clarified that the company’s Makena birth drug isn’t identical to lower-cost versions of the drug.
The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine said in a joint statement that physicians should understand the “inherent differences” between Makena, which has Food and Drug Administration approval, and drugs made using compounding processes.
Continue Reading Below
“Healthcare providers understand that evidence-based medicine is the foundation of clinical practice,” K-V Pharmaceuticals said in a statement. “Access to FDA-approved Makena for clinically-indicated patients is an important public health priority.”
Evidence from a study that supported the use of one of Makena's compounds, known as 17P, was based on Makena rather than a drug obtained from compounding pharmacies, the groups said. Certain payer coverage policies had been influenced by a false belief that the unapproved lower-cost drugs are the same as Makena.
“These policies should be modified to ensure that clinically-indicated patients have unencumbered access to FDA-approved Makena, consistent with their healthcare provider's medical judgment,” the drug maker said.
Makena is a hormone medicine that reduces the risk of a pre-term delivery in women who have delivered prematurely in the mast.
Shares of pharmaceutical giants Pfizer (NYSE:PFE) and Merck (NYSE:MRK) traded higher on Friday amid a broader market rally.