Progesterone for Preterm Birth
In April 2011, Columbia submitted an NDA for progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. On January 20, 2012, members of the FDA Advisory Committee for Reproductive Health Drugs panel generally agreed that progesterone vaginal gel 8% is safe, but the Committee stated that more information is needed to support approval. Columbia transferred the NDA to Watson Pharmaceuticals on February 10, 2012, for which Watson received a complete response letter (CRL) from the FDA. The CRL stated that the effect of treatment with progesterone vaginal gel 8% in reducing the risk of preterm birth in women with a short uterine cervical length at ≤ 32 6/7 weeks gestation (p=0.022) did not meet the level of statistical significance generally expected to support the approval of the product in the U.S. market from a single trial. Although not part of the requirements communicated to the sponsor during pre-Phase III meetings, the FDA also raised the issue of robustness in efficacy in the U.S. sub-cohort as compared to the overall efficacy of the trial. In the CRL, the FDA stated that additional clinical work would be required to support the approval. Watson is in discussions with the FDA regarding a potential pathway to approval for this application.
