Vera Therapeutics, Inc. ( VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the atacicept Biologics License Application (BLA) for the treatment of adults with immunoglobulin A nephropathy (IgAN) was accepted for Priority Review by the U.S. Food and Drug Administration (FDA). The BLA, which was submitted using the Accelerated Approval Program, was assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. If approved, atacicept could offer patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.
“Atacicept offers a distinct approach through dual targeting of BAFF and APRIL, which we believe could advance the standard of care in IgAN, if approved,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “FDA’s Priority Review designation reinforces the need for new therapies that can reshape the IgAN treatment landscape. We remain committed to working with the FDA to facilitate a thorough review of the BLA. Our team is focused on bringing a potential treatment to patients with the urgency they deserve.”
The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (pResults of the interim analysis were presented as a late-breaking oral presentation at the opening plenary session of the American Society of Nephrology Kidney Week meeting and published in a manuscript in the New England Journal of Medicine on November 6.
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