Columbia/Watson’s Progesterone Gel For Preterm Births Needs Additional Studies, Advisory Panel Says
This article was originally published in The Pink Sheet Daily
FDA’s Reproductive Health Drugs Advisory Committee recommended against approving the drug in twin 13-4 votes due to concerns about inconsistent foreign data. If the sponsors move forward with another trial, they may have to use a comparative, rather than placebo-controlled, design.
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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.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.
Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.