FDA Cancels AdComm Meeting to Review Testosterone Replacement Candidate
The FDA has cancelled a Nov. 3 advisory committee meeting to review Repros Therapeutics’ NDA for its testosterone replacement candidate enclomiphene.
The Division of Bone, Reproductive and Urologic Products had questions during its review regarding the bioanalytical method validation, which it said could affect how pivotal study data for the candidate is interpreted.
Previously known as Androxal, the candidate has a troubled history with the FDA. In 2012, the agency requested additional study data and an extended safety study, and in 2010, The Woodlands, Texas, firm was asked to revise its proposed indication. The company clarified that it is for men with low testosterone wishing to preserve fertility during treatment for their hypogonadal state.
The FDA accepted the NDA for review on April 1 and assigned it a PDUFA goal date of Nov. 30.