Novartis Reports FDA’s Acceptance of BLA for Brolucizumab (RTH258) to Treat Wet AMD

Shots:

• The BLA submission is based on P-III HAWK and HARRIER study results assessing brolucizumab (3/6 mg, q12w/q8w) vs aflibercept in 1800 patients with neovascular age-related macular degeneration nAMD or wet AMD at 400 sites
• P-III HAWK and HARRIER: @48wks. best-corrected visual acuity (BCVA) from baseline (6.6, 6.9 letters vs 6.8, 7.6 letters); patients with disease activity (23.5%, 21.9% vs 33.5%, 31.4%); key markers used by physicians to help guide management of the disease (31%, 26%)
• Brolucizumab (RTH258) is a single-chain antibody fragment (scFv) that inhibits VEGF receptors, with its expected launch in end of 2019. Novartis has utilized its Priority Review Voucher for brolucizumab’s FDA review

Click here to read full press release/ article | Ref: Novartis | Image: Business Journal