CALT - Calliditas gets EMA panel nod for conditional authorization of kidney disorder therapy

A committee of the European Medicines Agency (EMA) recommended the conditional marketing authorization for Calliditas Therapeutics' (NASDAQ:CALT) Kinpeygo to treat symptoms of primary immunoglobulin A nephropathy (IgAN). IgAN is a type of kidney disease which occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) for Kinpeygo (budesonide) is to treat primary IgA nephropathy in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio ?1.5 g/gram. The EMA said in May 20 release that the benefit of Kinpeygo is its ability to effectively reduce proteinuria. The drugwill be available as a 4-mg modified-release hard capsule. In December 2021, the FDA approved Calliditas'  budesonide, sold as Tarpeyo, to address proteinuria in adults with primary IgAN. The EMA noted that Kinpeygo is a hybrid therapy of Entocort which has been authorized in the EU since April 2, 1992. Kinpeygo

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Calliditas gets EMA panel nod for conditional authorization of kidney disorder therapy