Amgen resubmits denosumab
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amgen's Prolia (denosumab) is back under review at FDA for treatment of postmenopausal osteoporosis with a July 25 user fee date, the company announced Feb. 19. The firm's response to the October 2009 "complete response" letter was designated a Class II resubmission. Analysts had hoped for a Class I designation, which would have meant a two-month review (1Pharmaceutical Approvals Monthly, January 2010). The action letter, which addressed treatment and prevention of PMO, requested additional information on the design of Amgen's proposed post-marketing surveillance program and updated safety data. FDA also issued a "complete response" on the indications for prevention of bone loss due to hormone ablation therapy in breast and prostate cancer (2"The Pink Sheet" DAILY, Oct. 21, 2009). Amgen said that it continues to work with FDA "to determine appropriate next steps" for the other Prolia indications