Roche Report the US FDA’s Acceptance of BLA for Port Delivery System with Ranibizumab to Treat Neovascular Age-Related Macular Degeneration

 Roche Report the US FDA’s Acceptance of BLA for Port Delivery System with Ranibizumab to Treat Neovascular Age-Related Macular Degeneration

Shots:

  • The BLA submission is based on results from the P-III Archway study involves assessing PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy
  • Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment & achieved vision outcomes equivalent to patients receive ranibizumab (0.5mg, monthly IVT) & PDS showed non-inferiority & equivalent to monthly ranibizumab in a pre-specified study, well-tolerated with favorable benefit-risk profile
  • The EMA has also validated the PDS’ MAA & is currently under review while FDA expects to decide on approval by Oct 23, 2021

Click here to­ read full press release/ article | Ref: Roche | Image: Forbes

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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