Posted by Michael Wonder on 15 Apr 2019
Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD
15 April 2019 - Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab.
Novartis announced that the US FDA accepted the company's biologics license application for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD), also known as neovascular AMD, or nAMD.
Seeking to make brolucizumab available as quickly as possible, Novartis used a priority review voucher to expedite FDA review. If approved by the FDA, Novartis anticipates launching brolucizumab by the end of 2019.
