Calliditas gets additional seven-year orphan drug exclusivity for Tarpeyo

Shares of Sweden-headquartered Calliditas Therapeutics (Nasdaq Stockholm: CALT) were up 6.8% at 116.60 kronor by mid-morning after revealing a patent extension on its lead product.

Calliditas said that the US Food and Drug Administration (FDA) has granted an orphan exclusivity period of seven years for Tarpeyo (budesonide), expiring in December 2030, based on the company obtaining full approval with a new indication for this product.

Following full approval in December 2023, Tarpeyo is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) 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, the company noted.