CHMP recommends EU approval of Roche ’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss

Vabysmo (faricimab) simultaneously targets and inhibits two disease pathways that driveneovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME)The CHMP recommendation is based on results across four phase III studies: TENAYA and LUCERNE innAMD at year one, and YOSEMITE and RHINE in DME up to two yearsThe totality of the data across all studies innAMD and DME available to date showed that over 60% of people treated withVabysmo were able to extend treatment to every four months, while improving and maintaining visionIf approved,Vabysmo would offer the first new mechanism of action in over a decade for people in the EU withnAMD and DMEBasel, 22 July 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vabysmo®️ (faricimab) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). Based on this recommendation, a final decision regarding the approval of Vabysmo is expected from the European Commission in the near future.Neovascular AMD and DME are two leading causes of vision loss, together affecting over 40 million people worldwide.1,2,3,4 The current standards of care typically require eye injections every one to two months.5,6 Vabysmo has the potential to extend the time between eye inje...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news