Columbia’s Progesterone Faces FDA Skepticism Over Foreign Data At Advisory Committee

18 Jan 2012

• By Martin Berman-Gorvine

The agency rejects the sponsor’s statistical analysis and says there is no statistically significant evidence of efficacy in the U.S. population, and the product seems likely to face a request for another trial from the advisory panel.

FDA’s opinion that Juniper Pharmaceuticals Inc.’s progesterone gel 8% lacks statistically significant proof of efficacy in reducing preterm births among U.S. women with a short cervix, while stronger evidence in ex-U.S. populations is offset by the different racial makeup in the foreign sites, makes a difficult-to-surmount problem for the sponsor going into the Friday meeting of the Reproductive Health Drugs Advisory Committee.

The FDA reviewers also rejected the sponsor’s statistical analysis on a crucial point. The NDA was based on a single...