Everest Medicines licensing partner Calliditas Therapeutics AB  announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon^®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023.

Following full approval in December 2023, Nefecon^® 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.

"We congratulate our partner for receiving seven more years of market exclusivity for Nefecon^® in the US, which is a further testament of FDA's recognition of the drug's capability to preserve kidney function and significantly delay disease progression for all adult patients," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Nefecon^® represents a revolutionary first-in-disease therapeutic option for Chinese patients who have more rapid disease progression in IgAN with no effective treatment options. Following its NDA approval in mainland China in November and successful commercialization in Macau in December, we now look forward to Nefecon^®'s imminent commercial launch in mainland China to make the drug available to 5 million IgAN patients as soon as possible."

South Korea's Ministry of Food and Drug Safety granted Orphan Drug Designation status for Nefecon^® in November 2022.