A U.S. Food and Drug Administration panel has voted against Columbia Laboratories‘ (Nasdaq: CBRX) and Watson Pharmaceuticals’ (NYSE: WPI) progesterone vaginal gel 8% to reduce preterm birth in women, saying the panel requires more information.
The Advisory Committee for Reproductive Health Drugs said the gel did not produce a statistically significant reduction in preterm births among U.S. women.
The U.S. regulator is expected to decide whether to approve the gel next month, but it need not follow the recommendation of the panel when it does.
Preterm births have been on the rise for the past 20 years in the United States and account for about 12 percent of births, according to the Centers of Disease Control. Although KV Pharmaceuticals’ Makena was approved nearly two years ago for preterm birth in women with a history of the condition, Watson in Parsippany, New Jersey and Livingston, New-Jersey-based Columbia’s drug is for women with a short cervix.
“We will work with the FDA to address the Advisory Committee’s comments as the Agency finalizes its review of our NDA,” said Frank Condella, president and CEO of Columbia Laboratories. “We hope the agency’s final decision will acknowledge the clear unmet medical need in this patient population.”
Flickr photo by dssimon]
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