- That European Commission approved Roche Holding Ltd RHHBY Vabysmo (faricimab) for neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME).
- These retinal diseases affect more than 40 million people worldwide.
- Vabysmo is the only injectable eye medicine approved in Europe with Phase 3 studies supporting treatment up to four months apart for people with nAMD and DME.
- also read: WHO recommends against Roche to deprecate GSK’s COVID-19 therapies
- The approval is based on four phase 3 studies with 3,220 patients. The studies showed that patients treated with Vabysmo up to every four months had similar results to those treated with aflibercept every two months.
- The pooled data from all four studies after two years showed that more than 60% of people treated with Vabysmo were able to extend treatment to every four months while improving and maintaining vision.
- In addition, patients with nAMD and DME treated with Vabysmo received a median of 33% (10 vs. 15) and 21% (11 vs. 14), respectively, fewer injections than aflibercept for up to two years.
- Vabysmo is now approved in the European Union and nine other countries. More than 100,000 Vabysmo doses have been distributed worldwide.
- Price promotion: RHHBY shares traded 1.70% lower at $41.63 on the latest check Monday.
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