Vera’s Trutakna wins FDA nod as first dual inhibitor for IgAN
· jennifer boggs
AI Briefing
- • Vera Therapeutics Inc. gets FDA clearance for Trutakna, first dual BAFF/APRIL inhibitor for IgAN.
- • Trutakna reduces proteinuria in adults with primary IgAN at risk for disease progression.
- • FDA approval gives Vera a nearly five-month head start over competitor Vertex Pharmaceuticals Inc.
Source Summary
Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector.
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