Ophthalmic Bevacizumab Sponsor Braces For High-Stakes EMA Meeting
The sponsor of an ophthalmic formulation of bevacizumab is set to speak up for its marketing authorization application during a European Medicines Agency oral explanation meeting.
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This week could finally see an ophthalmic version of the anticancer drug bevacizumab recommended for use in wet AMD across the EU. Several other new products are also up for a CHMP opinion.
Sponsors of six new products, including a first-in-class treatment for unresectable locally advanced or metastatic triple-negative breast cancer, will find out this week if their products are on course to be approved for use in the EU. Also, two sponsors might be asked to address last-minute questions about their drugs.
The sponsor of what could become the EU’s first approved ophthalmic formulation of bevacizumab needs to address outstanding issues raised by the European Medicines Agency about its filing.