Novartis Submits New Indication Application for Brolucizumab in China, Likely for Wet Age-Related Macular Degeneration
Novartis
Drug Development and Manufacturing
On October 12, the CDE website showed that Novartis' Brolucizumab new indication was submitted for marketing in China, and the speculated indication is wet age-related macular degeneration.
Screenshot source: CDE official website
Brolucizumab, developed by Novartis, is a full VEGF-A inhibitor and a new type of humanized drug.Single-chain antibody fragment, with a molecular weight of only 26kDa, high affinity, strong tissue penetration, and minimal systemic side effects. It was first approved for marketing in the United States on October 7, 2019, for the treatment of wet age-related macular degeneration, and in June 2022, it was also approved for diabetic macular edema.
ClothCixutumumab at the FDAThe approval was based on the results of the Phase III HAWK and HARRIER clinical trials, in which,ClothXizhu Monoclonal AntibodyIn terms of the average change in Best Corrected Visual Acuity (BCVA) at Week 48 of Year 1Non-inferior to Aflibercept。
In two clinical trials, approximately 30% of patients had an increase in vision of at least 15 letters by Year 1. In HAWK and HARRIER,ClothXizhu Monoclonal AntibodyA greater reduction in central subfield thickness (CST) was observed as early as Week 16 and Year 1, with fewer patients showing intraretinal (IRF) and/or subretinal fluid (SRF). Retinal fluid is a key marker of disease activity.
The injection frequency of Brolucizumab isOnce every 3 months, while ranibizumab and aflibercept are administered once a month, followed by on-demand treatment after 3-5 consecutive doses, so brolucizumab has an advantage in terms of dosing frequency.
Currently, brolucizumab has not yet been approved for marketing in China; the first marketing application was submitted domestically in August 2023, with the speculated indication beingDiabetic Macular Edema, expected to be approved in Q1 2025.
