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First and only drug for primary IgA nephropathy approved in Europe

 Last Update: 2022-08-15
 Source: Internet
 Author: User

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Recently, Calliditas Therapeutics announced that the European Commission (EC) has granted a conditional marketing authorization for Kinpeygo® for the treatment of primary immunoglobulin in adults at risk of rapid disease progression and with a urine protein-to-creatinine ratio (UPCR) ≥5 g/g A (IgA) nephropathy (primary immunoglobulin A (IgA) nephropathy, IgA.

Kinpeygo is an orphan drug, the first and only drug approved for the treatment of IgAN

The first and only drug approved for the treatment of IgAN

The Conditional Marketing Authorisation applies to all 27 EU member states as well as Iceland, Norway and Liechtenste.

The approval of Kinpeygo is based on efficacy and safety data from Part A of the pivotal Phase 3 study of NeflgArd, an ongoing, randomized, double-blind, placebo-controlled, multicenter study evaluating Kinpeygo 16 mg once daily Efficacy and safety of oral doses versus placebo in adult patients with primary Ig.

The data showed that patients taking 16 mg of Kinpeygo once daily had a statistically significant 31% reduction in proteinuria from baseline after 9 months of treatment, compared with a statistically significant 5% reduction in the placebo gro.

Original title: European Commission approves Kinpeygo® for adults with primary IgA nephropathy

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