The U.S. FDA approved Vera Therapeutics' injectable drug Trutakna for immunoglobulin A (IgA) nephropathy, also called Berger's disease. Trutakna is a self-administered therapy that targets immune proteins BAFF and APRIL to reduce production of disease-related antibodies. The approval is a regulatory milestone for a condition that can lead to progressive kidney damage and eventual failure. Vera Therapeutics' shares rose 6.2% after the announcement.
FDA Approves Vera Therapeutics' Trutakna for IgA Nephropathy; Shares Jump 6.2%
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly
The U.S. Food and Drug Administration has approved Vera Therapeutics' drug Trutakna for the treatment of immunoglobulin A (IgA) nephropathy, a potentially life-threatening kidney disorder, the agency said on Tuesday.
What Trutakna Treats
IgA nephropathy, also known as Berger's disease, is characterized by abnormal protein and antibody deposits in the kidneys that can lead to progressive kidney damage and, in some cases, kidney failure. Trutakna is approved for self-administration as an injectable therapy for patients with this condition.
How It Works
Trutakna targets the immune-system proteins BAFF and APRIL, which play roles in the production of antibodies implicated in IgA nephropathy and other autoimmune disorders. By modulating these proteins, the treatment is intended to reduce the production of disease-driving antibodies and slow disease progression.
Market Reaction And Significance
Following the FDA announcement, Vera Therapeutics' shares rose 6.2% in afternoon trading. The approval represents a notable regulatory milestone for treatments specifically aimed at an uncommon but serious kidney disease and may broaden therapeutic options for patients who currently have limited choices.
(Reporting by Siddhi Mahatole and Puyaan Singh in Bengaluru; Editing by Vijay Kishore)
Help us improve.
