FDA approves Tarpeyo to reduce proteinuria in IgA nephropathy
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The FDA granted accelerated approval for Calliditas Therapeutics’ drug Tarpeyo, also known as budesonide, making it the first and only FDA-approved treatment for reducing proteinuria in IgA nephropathy, according to a company press release.
Tarpeyo delayed-release capsules are designed to lower proteinuria in adults with primary IgA nephropathy (IgAN) who are also at risk of rapid disease progression. Tarpeyo gained FDA approval after accomplishing a primary endpoint in a randomized, double-blind study. Patients who took Tarpeyo 8 mg daily experienced an average 34% reduction in urine protein-to-creatinine ratio compared with patients who took a placebo and had an average 5% reduction.
“Tarpeyo was developed to target a root cause of IgAN,” Richard Philipson, MD, chief medical officer of Calliditas, said in the release. “The FDA’s approval of Tarpeyo demonstrates our unwavering dedication to patients suffering from IgAN.”
Calliditas plans to make Tarpeyo available in the U.S. in early 2022.
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