As Brolucizumab moves closer to clinical approval for additional indication, what is the likelihood that the drug will be approved?

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 LoA and 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.

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