Vera Therapeutics Says FDA Grants Breakthrough Therapy Designation For Atacicept To Treat IgAN
(RTTNews) - Biotechnology company Vera Therapeutics, Inc. (VERA) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of Immunoglobulin A Nephropathy or IgAN.
The designation reflects the FDA's determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial of atacicept for IgAN, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN.
As part of the Breakthrough Therapy Designation request, the FDA reviewed data from the Phase 2b ORIGIN trial of atacicept in IgAN which demonstrate the stabilization of eGFR over 72 weeks of treatment.
The participants first received atacicept in a 36-week double-blind period, and then continued to receive atacicept 150 mg self-administered subcutaneously once weekly at home during 36 additional weeks of open-label follow-up.
The company now plans to announce long-term 96-week results from the Phase 2b ORIGIN trial later this year. It also expects the primary endpoint results from our pivotal Phase 3 ORIGIN 3 trial in the first half of 2025, which are anticipated to support submission for regulatory approval of atacicept in IgAN.
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