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Novartis Submits BLA for Brolucizumab in Wet AMD Using Priority Review Voucher, Aims for 2019 Launch

Apr 16, 2019 09:54 CST Updated 09:54
Novartis

Drug Development and Manufacturing

FDA

U.S. Food and Drug Administration

▎WuXi AppTecKangde / Report

Today, Novartis announced that it has submitted a Biologics License Application to the U.S. FDA for brolucizumab, a treatment for wet age-related macular degeneration (AMD). To expedite the availability of this new therapy to patients,Novartis used a priority review voucher to expedite the FDA's review process., if approved by the FDA,Novartis expects to launch this innovative therapy by the end of 2019.。


Wet AMD is the leading cause of severe vision loss in individuals aged 65 and older, affecting approximately 20 to 25 million people worldwide. Wet AMD results from the growth of abnormal blood vessels beneath the macula; these fragile vessels leak fluid, damaging normal retinal structure and ultimately leading to macular impairment.

Brolucizumab is a humanized single-chain antibody variable region fragmentIt binds with high affinity to all VEGF-A isoforms, inhibiting their functions and the activation of VEGF receptors. Inhibition of the VEGF signaling pathway can suppress the growth of neovascular lesions, resolve retinal edema, and improve patients' vision.

▲Comparison of the Molecular Weight of Brolucizumab with Other Therapies for Wet AMD (Image Source: Reference [2])

This application is based on data obtained from the Phase 3 clinical trials named HAWK and HARRIER. In these two trials,Brolucizumab met the non-inferiority criteria compared with the approved therapy aflibercept in improving patients’ visual acuity.Moreover, with respect to the key secondary endpoints,The proportion of patients showing disease activity among those treated with brolucizumab was significantly lower than that in the control group.(23.5% vs 33.5%, HAWK trial; 21.9% vs 31.4%, HARRIER trial, p=0.0022). Meanwhile, patients treated with brolucizumab had significantly less retinal fluid than the control group.

“Achieving this milestone is an important step in changing the treatment journey for patients with wet AMD,” said Mr. Fabrice Chouraqui, President of Novartis Pharmaceuticals Corporation. “We look forward to seeing this new treatment option demonstrate its potential in patients with wet AMD.”

References:

[1] Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD. Retrieved April 15, 2019, from https://www.novartis.com/news/media-releases/novartis-announces-fda-filing-acceptance-and-priority-review-brolucizumab-rth258-patients-wet-amd

[2] A Novel Compound for Treatment of Wet AMD. Retrieved October 29, 2018, from http://retinatoday.com/2016/06/a-novel-compound-for-treatment-of-wet-amd/


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