STOCKHOLM, Sweden — Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) today 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® (budesonide) is indicated ‘to reduce the loss of kidney function in adults with primary IgA 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.
“We are delighted to have seven years of market exclusivity expiring in December 2030 for TARPEYO in the US, reflecting the new indication based on the long-term data generated,” said CEO Renée Aguiar-Lucander.
For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: [email protected]