Ionis Pharmaceuticals, Inc. (IONS) partner GSK on Tuesday announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for Bepirovirsen, for the treatment of adults with chronic hepatitis B or CHB, a viral infection that can cause both acute and chronic liver disease.
In addition, the FDA has granted Bepirovirsen a Breakthrough Therapy or BT designation and has set a Prescription Drug User Fee Act (PDUFA) target action date of October 26, 2026.
Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to recognise and inhibit the production of the hepatitis B virus's genetic components, which can lead to chronic disease. GSK licensed Bepirovirsen from Ionis in 2019 under a collaborative development and licensing agreement.
The regulatory submission and Breakthrough Therapy designation were supported by positive results from the Phase 3 B-Well 1 and B-Well 2 trials, where Bepirovirsen demonstrated statistically significant and clinically meaningful functional cure rates.
The B-Well 1 and B-Well 2 trials are global, multicentre, randomised, double-blind, placebo-controlled trials conducted in 29 countries.
They assessed the efficacy, safety, pharmacokinetic profile, and the durability of functional cure in nucleos(t)ide analogue (NA)-treated participants with chronic hepatitis B.
Bepirovirsen demonstrated an acceptable safety and tolerability profile consistent with previous studies.
Bepirovirsen is currently under regulatory review with the European Medicines Agency, the China National Medical Products Administration, and Japan's Ministry of Health, Labour and Welfare.
IONS has traded between $29.42 and $86.74 over the last year. The stock closed Monday's trade at $72.23, down 1.42%.
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