Genentech Lucentis priority review
This article was originally published in Pharmaceutical Approvals Monthly
Genentech's BLA for its wet age-related macular degeneration treatment Lucentis (ranibizumab) is granted a priority review at FDA, giving the VEGF antibody a June 29 user fee goal date. Genentech's submission includes a head-to-head trial with Novartis/QLT's photodynamic therapy Visudyne (verteporfin). Genentech has referred to Lucentis as the first wet AMD treatment to show a clinical benefit over PDT in a head-to-head study setting (1Pharmaceutical Approvals Monthly June 2005, p. 12). In conjunction with the priority review designation, Genentech announced preliminary, two-year data from its Phase III MARINA study showing improvement at two years...
You may also be interested in...
Alcon expects to meet with FDA in July to discuss a May 23 "approvable" letter for its wet age-related macular degeneration agent Retaane (anecortave acetate suspension)
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.