Posted by Michael Wonder on 14 May 2024
Outlook Therapeutics announces UK submission of marketing authorisation application for ONS-5010 as a treatment for wet AMD
13 May 2024 - Outlook Therapeutics today announced the submission of its marketing authorisation application to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom seeking authorisation of ONS-5010/Lytenava (bevacizumab gamma) for the treatment of wet age-related macular degeneration.
The submission was completed under the new International Recognition Procedure, which allows the MHRA to rely on a positive opinion by the EMA’s CHMP concerning an application for grant of marketing authorisation for the same product in the EU.
