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Columbia’s Prochieve Could Get Competitive Edge From Committee Review Of Rival Product

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA panel review of Adeza’s Gestiva endorses endpoints being used in Columbia’s Phase III trial of its preterm birth agent.

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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.

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If approved, Adeza’s long-acting form of progesterone would be the first FDA-approved treatment for preterm birth.

FDA “Approvable” Letter For Gestiva Recommends Additional Animal Study

If approved, Adeza’s long-acting form of progesterone would be the first FDA-approved treatment for preterm birth.

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