Research & Development
US FDA accepts Novartis' biologics license application for brolucizumab
18 April 2019 -

The United States Food and Drug Administration (FDA) has accepted a biologics license application (BLA) from Switzerland-based Novartis for brolucizumab (RTH258) as a potential treatment for wet age-related macular degeneration (AMD), it was reported yesterday.

The company stated that it used a priority review voucher to fast track the regulator's review of brolucizumab in order to make it available to patients as quickly as possible. The BLA for the product is mainly based on the findings of the HAWK and HARRIER phase three trials, which featured more than 1,800 patients. The Novartis drug met the primary efficacy objective of non-inferiority compared to aflibercept in mean change in best-corrected visual acuity from baseline to week 48 by demonstrating high statistical significance. In addition, the product indicated superiority in three secondary endpoints, central subfield retinal thickness, retinal fluid and disease activity, which are considered key parameters of nAMD.

The company expects the drug to be launched by the end of 2019 if it is approved by the US FDA.