Calliditas gets additional seven year orphan drug exclusivity period for Tarpeyo

Calliditas Therapeutics announced that the FDA has granted an orphan drug exclusivity period of seven years for Tarpeyo, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full approval in December 2023, Tarpeyo is indicated ‘to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy who are at risk for disease progression’. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN.