Roche Reports the US FDA’s Acceptance of BLA for Faricimab to Treat Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

July 29, 2021 Auto Bot Acceptance, BLA, Diabetic Macular Edema, FDA, Neovascular Age-Related Macular Degeneration, regulatory, Roche 0

Shots:

  • The BLA submission is based on four P-III studies i.e TENAYA, LUCERNE, YOSEMITE & RHINE evaluating the efficacy & safety of faricimab vs aflibercept in patients with nAMD & DME. The LTE studies for faricimab are underway
  • The studies demonstrated non-inferior visual acuity gains and greater reductions in CST, ~50% of patients can extend treatment time to every 4mos. in the 1st yr. in nAMD & DME studies. The therapy was well tolerated with no new safety signals identified
  • If approved, Faricimab will be the first bispecific Ab designed to target two pathways i.e., Ang-2 and VEGF-A for retinal disorders. The EMA has also validated the MAA of faricimab for nAMD & DME

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Spain’s News

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