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

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...

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