Watson Pharmaceuticals Inc. (WPI) along with partner Columbia Laboratories Inc. (CBRX) recently announced that the US Food and Drug Administration (:FDA) has issued a complete response letter (CRL) to the companies’ new drug application (:NDA) for progesterone vaginal gel 8%. The gel was under review for use in the reduction of risk of preterm birth in women with a singleton gestation and a short uterine cervical length in the mid-trimester of pregnancy.
In the letter, the regulatory body has stated that the candidate did not meet the level of statistical significance required from a single trial to gain US approval. The FDA also had concerns about the robustness in efficacy in the US sub-cohort as compared to the overall efficacy of the trial. The regulatory body also stated that an additional clinical trial will be required to get the gel approved.
Watson Pharma and Columbia Labs had filed for the US approval of the gel in June 2011.
We note that the news of the CRL did not come as a surprise since in January the FDA’s advisory committee had recommended against the approval of the candidate. The committee had said that the gel is safe but added that it needed more information in order to recommend the candidate for approval.
Earlier, in February, Columbia Labs had transferred the NDA for the gel to Watson Pharma. The transfer did not involve any additional payment and following the transfer Watson Pharma gained full rights and regulatory responsibilities for all activities relating to the application.
According to the original agreement entered into by the companies last year, Watson Pharma had acquired the US rights to progesterone vaginal gel 8% and Crinone from Columbia Labs. Crinone is available for the treatment of infertility in women. According to the agreement, Columbia Labs receives royalties on net sales made by Watson Pharma. Outside the US, Crinone is marketed by Merck KGaA (MKGAY).
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