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Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo

Stada To Commercialize In EU

 
• By Ayisha Sharma

The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.  

Tarpeyo Now Has Two Major Regulatory Thumbs Ups • Source: Shutterstock

STADA Arzneimittel AG is getting ready to commercialize Calliditas Therapeutics AB’ nephrology product, Tarpeyo, now that it has received a positive opinion from the EU’s Committee for Medicinal Products for Human Use (CHMP) for it after an initial pushback from the body.

The CHMP issued a positive opinion on the EU approval of Tarpeyo (delayed-release budesonide) in immunoglobulin A nephropathy (IgAN) patients at risk of rapid disease progression with a urine protein-to-creatinine ratio of at least 1.5g/gram. The European Commission (EC) should confirm the decision by the third quarter, making Tarpeyo the first and only approved drug for IgAN on both sides of the Atlantic

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