On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization (MA) for Outlook Therapeutics’ Lytenava (ONS-5010, bevacizumab gamma), intended for treatment of neovascular (wet) age-related macular degeneration (nAMD).
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumors and is used to treat various cancers [1]. The originator reference product is Roche’s originator, Avastin.
Lytenava/ONS-5010 (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD and other retinal diseases. As FDA or European Commission (EC) approved ophthalmic bevacizumab formulations are lacking, clinicians resort to repackaged IV bevacizumab from compounding pharmacies, which pose contamination and potency risks. Lytenava/ONS-5010, if approved, would offer physicians a sanctioned option for treating wet AMD.
Outlook Therapeutics is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.
The CHMP positive opinion was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and bibliographic literature substituting or supporting certain tests and studies. If approved, an initial 10 years of market exclusivity in the European Union (EU) is expected for ONS-5010/LYTENAVA.
Pending the decision/approval of the MA from the EC, Lytenava will be available as 25 mg/ml solution for injection in Europe.
However, following the submission of their Biologics License Application (BLA) in the US, in August 2023, the US Food and Drug Administration (FDA) did not approve Lytenava and issued a complete response letter (CRL). In this letter, the FDA acknowledged that Outlook Therapeutics’ NORSE TWO pivotal trial met its safety and efficacy endpoints. However, the FDA stated that they could not approve the BLA during this review cycle due to 'several CMC issues, open observations from preapproval manufacturing inspections, and a lack of substantial evidence'.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 22]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
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