Just weeks ago, after FDA regulators and agency experts lined up squarely against an approval for a vaginal gel from Columbia Laboratories ($CBRX) and Watson Pharmaceuticals to reduce the risk of preterm birth, Columbia's CEO declared himself convinced of the justification for a formal approval. This morning, when the company revealed that the FDA had rejected the application, Columbia announced that it had been handed a complete response letter "as expected."
The company stood by its complaint that regulators had zeroed in on something they never expected: The robustness--or lack thereof--of the sub-cohort of U.S. patients in the study. The agency has made it officially clear now that it wants more clinical evidence of efficacy for Prochieve before it hands out an approval.
"Watson will work directly with the FDA to address items raised in the complete response letter regarding the approvability of progresterone vaginal gel 8% for reduction of preterm birth. We have formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application," said Paul M. Bisaro, Watson's CEO. "We believe that there is a significant unmet medical need for a safe and effective treatment of patients at risk for preterm birth which affects approximately one-in-eight live-born infants in the U.S."
The writing on the wall for this treatment started last summer, when Columbia failed to achieve a priority review for the treatment. Then in January regulators flatly stated that investigators never presented sufficient data to make their case, and the experts agreed days later.
Evidently the rejection still caught a few people by surprise. Columbia's shares fell another 8% in premarket trading.
- here's the press release