European Commission grants Marketing Authorisation for bevacizumab gamma

The European Commission’s decision follows the submission of an MAA in the UK earlier this month. Image credit: ©Sergii Figurnyi – stock.adobe.com

Outlook Therapeutics, Inc. announced the European Commission has granted Marketing Authorisation for bevacizumab gamma (ONS-5010/LYTENAVA™), the company’s ophthalmic formulation of bevacizumab. In a press release, Outlook Therapeutics announced that the approval will help advance the company toward the commercial launch of bevacizumab gamma, expected in Q1 2025.¹ The formulation is the first in the European Union to be approved for use in treating wet age-related macular degeneration (AMD).

Outlook Therapeutics received marketing authorisation from the European Commission for a mixed application, which was submitted based on the results from the completed registration clinical trials NORSE ONE, NORSE TWO and NORSE THREE. Supporting studies and peer-reviewed literature were also considered. The authorisation applies automatically in all 27 EU Member States; within 30 days, the approval extends to Iceland, Norway and Liechtenstein. The Marketing Authorisation also grants Outlook Therapeutics an initial 10 years of market exclusivity for bevacizumab gamma in the EU.

Bevacizumab-vikg, bevacizumab gamma in the EU and United Kingdom, is a recombinant humanised monoclonal antibody anti-vascular endothelial growth factor (VEGF) agent. Outlook Therapeutics is also awaiting a decision on its Marketing Authorisation Application (MAA) to the Medicines and Healthcare products Regulatory Agency in the UK, seeking approval of bevacizumab gamma for the treatment of wet AMD. The European Commission’s issuance of a Marketing Authorisation follows the submission of an MAA in the UK earlier this month.²

In the United States, bevacizumab gamma is currently undergoing evaluation for its use in treating wet AMD in a non-inferiority study.

“This is a landmark milestone for us,” said Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, in the news release.¹ “The EU represents the second largest wet AMD market in the world, and we look forward to continuing our efforts to bring to the EU market the first and only on-label, ophthalmic bevacizumab for the treatment of wet AMD. We are incredibly grateful to all the patients, researchers, clinical sites and the European Medicines Agency for the research, drug development, and regulatory efforts that led to this approval.”

References

1. Outlook Therapeutics® Receives European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD. News release. Outlook Therapeutics, Inc. and Cencora. Published 29 May, 2024. Accessed 29 May, 2024.

2. Hayes H. Outlook Therapeutics submits UK Marketing Authorisation Application for wet AMD treatment. Ophthalmology Times Europe. Published 13 May, 2024. Accessed 29 May, 2024. https://europe.ophthalmologytimes.com/view/outlook-therapeutics-submits-uk-marketing-authorisation-application-for-wet-amd-treatment