Brolucizumab is under clinical development by Athenex and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Brolucizumab’s likelihood of approval (LoA) and phase transition for Proliferative Diabetic Retinopathy (PDR) took place on 01 Apr 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Brolucizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Brolucizumab overview

Brolucizumab-dbll (Beovu, Vsiqq, Vizcu, Pagenax) is a recombinant human vascular endothelial growth factor. It is formulated as solution for intravitreal route of administration. Beovu is indicated for the treatment of neovascular (Wet) age-related macular degeneration. Beovu is indicated for the treatment of diabetic macular edema.

Brolucizumab (DLX-1008) is under development for proliferative diabetic retinopathy. It is administered topically and intravitreally. The therapeutic candidate targets VEGF-A and is developed based on the Pentra technology platform which utilizes Pentra antibody fragments. It was also under development for the treatment of keloids, rosacea, Kaposi's sarcoma, diabetic macular edema and glioblastoma.

It was under development for the treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion, macular edema secondary to central retinal vein occlusion.

Athenex overview

Athenex, formerly known as Kinex Pharmaceuticals, is a biopharmaceutical company focused on the discovery, development of autologous and allogeneic CAR-NKT cell therapies to treat cancers. The company’s product pipeline includes KUR-501–GD2, KUR-502–CD19, KUR-503–GPC3 and p53-KRAS and EGFR. Athenex platform includes oncology innovation Platform for research and development, commercial platform for manufacturing and marketing of products and global supply chain which provide APIS to clinical and commercial effort. The company partners with pharmaceutical companies, universities and research institutions for the advancement and commercialization of its products. It has operations with product manufacturing facilities in the US, China, Taiwan and Hong Kong. Athenex is headquartered in Buffalo, New York, the US.

Quick View Brolucizumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Brolucizumab
Administration Pathway
  • Intravitreal
  • Topical
Therapeutic Areas
  • Dermatology
  • Infectious Disease
  • Metabolic Disorders
  • Oncology
  • Ophthalmology
Key Developers
  • Sponsor Company: Athenex
  • Originator: ESBATech
Highest Development Stage
  • Marketed

GlobalData

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.