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Calliditas’ Nephrology Gem Tarpeyo Faces EU Regulatory Delay

CHMP Has Manufacturing Questions

 
• By Ayisha Sharma

The Swedish biotech’s oral corticosteroid for a kidney disorder has left the EMA’s CHMP with questions on its manufacturing, delaying an EU approval opinion that had been slated for the first quarter.    

Hands holding a kidney, paper cut out, world kidney day, health problems, organ transplantation, medical issue
Some IgAN Patients Are At Risk Of End-Stage Renal Failure • Source: Alamy

Calliditas Therapeutics AB’s Tarpeyo (nefecon) for rare disease immunoglobulin A nephropathy (IgAN) has stumbled on the path to EU approval as a request for more manufacturing information delays an opinion on its approvability, delaying its debut in a pent-up market.

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