Novartis Announces FDA Approval of Beovu (brolucizumab) for Neovascular AMD with Quarterly Dosing

Source:PharmaCube Info

Author: Baihuawen

On October 8, Novartis announced that the FDA had approved Beovu (brolucizumab, RTH258) for marketing to treat wet age-related macular degeneration (wet-AMD, nAMD). Novartis submitted the Biologics License Application (BLA) for brolucizumab on April 17 of this year and used a priority review voucher worth $130 million to shorten the approval cycle for brolucizumab to six months.

This approval is based on data from two head-to-head Phase III clinical studies, HAWK and HARRIER. The results demonstrated that the mean change in best-corrected visual acuity (BCVA) at 48 weeks in patients treated with Beovu was non-inferior to that of aflibercept, with a comparable safety profile. Patients treated with Beovu showed a substantial reduction in central subfield thickness (CST) at Week 16 and at one year, along with less intraretinal fluid (IRF) and/or subretinal fluid (SRF), which are key indicators of disease activity.

Source: Novartis Official Website

Notably, in the HAWK and HARRIER studies, eligible patients could immediately maintain a 3-month dosing interval after the loading phase. During the first year, more than half of the patients maintained a 3-month dosing interval (56% in the HAWK study and 51% in the HARRIER study), while the remaining patients had a 2-month dosing interval.

Wet age-related macular degeneration (AMD) is a chronic degenerative eye disease caused by excessive proliferation of submacular blood vessels. Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of abnormal blood vessels beneath the macula, which is the retinal region responsible for clear central vision. Fluid leakage from these abnormal vessels disrupts normal retinal architecture and ultimately damages the macula.

Brolucizumab is a humanized single-chain antibody fragment (scFv) and represents the most advanced humanized scFv currently in clinical development. Due to its small size, strong tissue penetration, rapid clearance from systemic circulation, and favorable drug release characteristics, brolucizumab has garnered significant attention in drug development.

This patented innovative structure results in a smaller drug molecule (26 kDa) with potent inhibitory activity and high affinity for all vascular endothelial growth factor A (VEGF-A) isoforms. In preclinical studies, brolucizumab inhibited the activation of VEGF receptors by blocking ligand-receptor interactions.

Comparison of the Molecular Weight of Brolucizumab with Other Therapies for Wet AMD

According to statistics, AMD affects over 20 million people worldwide each year and is the leading cause of blindness in patients aged 65 and older. The need for frequent intravitreal injections is the primary reason why AMD patients ultimately discontinue treatment. Beovu improves vision by inhibiting the VEGF signaling pathway, thereby suppressing abnormal vascular proliferation and fluid leakage into the retina. Compared with aflibercept, Beovu demonstrates superior efficacy in resolving retinal fluid and allows for quarterly dosing, thus improving the quality of life for AMD patients.

References:

[1] Novartis Official Website. Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept.