Argenx, Calliditas Hit The Ground Running After FDA Approvals
Green Lights For Vyvant and Tarpeyo
Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.
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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.
The generalized myasthenia gravis-approved drug passed the $20m mark in sales for the first quarter, comfortably surpassing analyst estimates.
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.