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Big Molecule Watch
July 12, 2024

Outlook Therapeutics Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma)

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On July 08, 2024, Outlook Therapeutics announced it received marketing authorization from UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD in the UK.  As we previously reported, Outlook Therapeutics received marketing authorization for LYTENAVA in the EU on May 28, 2024. With these approvals, LYTENAVA is the first and only ophthalmic formulation of bevacizumab to treat wet AMD in the EU and UK.  Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, stated “[w]e are pleased to receive UK approval on the heels of marketing authorization in the EU for LYTENAVA (bevacizumab gamma). This milestone achievement is the final regulatory step towards our expected commercial launch in the EU and UK in the first calendar quarter of 2025.”

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