Allergan and Molecular Partners Report Acceptance of FDA’s BLA and Validation of EMA’s MAA for Abicipar Pegol

 Allergan and Molecular Partners Report Acceptance of FDA’s BLA and Validation of EMA’s MAA for Abicipar Pegol

Allergan Reports FDA’s Acceptance of NDA for Bimatoprost Sustained-Release to Treat Glaucoma or Ocular Hypertension

Shots:

  • The BLA and MAA are based on P-III CEDAR and SEQUOIA studies assessing Abicipar (quarterly dosing regimen) vs ranibizumab in patients with neovascular (wet) age-related macular degeneration resulting in maintaining vision gains with 6/8 vs 13 injection @52wks. with its expected approval in H2’2020 in the US & EU
  • The acceptance of the FDA’s BLA is an important milestone for the Molecular’s DARPin technology as Abicipar is the first DARPin candidate to receive the FDA’s acceptance
  • DARPin molecules are genetically engineered Ab mimetic protein, exhibiting high-affinity target protein binding, derived from natural ankyrin protein and are being evaluated for ophthalmology, oncology and immuno-oncology

Click here to­ read full press release/ article | Ref: Allergan | Image: WSJ

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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