FDA Does Not Give Denosumab Priority Review

The FDA is giving Amgen’s denosumab a 10-month review period although the company requested priority review for its BLA. The Prescription Drug User Fee Act action date is Oct. 19. Amgen is seeking two separate indications for its investigational biologic — one to prevent postmenopausal osteoporosis and the second to prevent bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The company submitted its BLA Dec. 19.
Washington Drug Letter