Tag Archive for: kidney disease

Calliditas announces an additional seven year orphan drug exclusivity period for TARPEYO®

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) 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 […]

Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in December 2021 under accelerated […]

Calliditas Therapeutics announces full results from the NefIgArd Phase 3 trial published in The Lancet

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced publication in The Lancet of the full data from the Phase 3 NefIgArd Study with Nefecon® (TARPEYO® (budesonide) delayed release capsules/Kinpeygo®) in adults with Primary IgA nephropathy (IgAN). The Phase 3 trial met the primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon demonstrating significant kidney protective effect over […]

Novo Nordisk Foundation grants DKK 25 million ($3.3 million) for completion of clinical trial to improve treatment outcomes for people with critical limb ischaemia

The grant will enable leading international researchers to complete a clinical trial comparing the two most common treatment methods for preventing leg amputation among people with critical limb ischaemia. Critical limb ischaemia is a serious and debilitating disease that affects about 22 million people globally, and these are often people with diabetes and/or chronic kidney […]