New medicine for diabetic macular edema!

Novartis recently announced that the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Medicines and Medical Devices Administration (PMDA) have accepted a new generation of ophthalmic drug Beovu (brolucizumab, 6mg) for the treatment of diabetes Application for Sexual Macular Edema (DME)

If approved, DME will become Beovu's second indication after being approved to treat wet age-related macular degeneration (wet-AMD) in October 2019 (U.

Beovu's application for the treatment of DME is based on one year of two randomized, double-blind, dual-simulation phase 3 clinical trials (KESTREL, KITE) evaluating Beovu (brolucizumab, 6mg) and Eylea (aflibercept, aflibercept, 2mg) for the treatment of DME Data

KESTREL and KITE are the first key clinical trials evaluating an anti-VEGF drug with a 6-week dosing interval during the loading period.

In terms of safety, in general, Beovu showed a good benefit risk profile in 2 trials

Wet AMD (wet-AMD, picture source retinaboston.

DME is the main cause of blindness among diabetic patients, affecting 21 million people worldwide, among which type 1 diabetes patients account for 12% and type 2 diabetes patients account for 28%

Beovu is a new generation of anti-vascular endothelial growth factor (VEGF) drug.

Wet age-related macular degeneration (wet-AMD, nAMD) is the main cause of blindness, affecting more than 20 million people worldwide.

The active pharmaceutical ingredient of Beovu is brolucizumab (RTH258), which is a humanized single-chain antibody fragment (scfv) that targets all types of vascular endothelial growth factor-A (VEGF-A)

The innovative structure of brolucizumab makes it only 26kDa in size, has a strong inhibitory effect on all subtypes of VEGF-A, and has a high affinity

In China, Beovu has entered phase 3 clinical research, developed for indications such as wet AMD and diabetic retinopathy

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Original source: Novartis announces FDA and EMA filing acceptances of Beovu® for patients with diabetic macular edema