CALT - Everest's kidney disease drug Nefecon gets fast track review status in South Korea

• Calliditas Therapeutics' ( OTCPK:CLTEF ) ( NASDAQ: CALT ) partner Everest Medicines said the Korea Ministry of Food and Drug Safety (MFDS) granted global innovative product on fast track (GIFT) designation to Nefecon to treat primary immunoglobulin A nephropathy (IgAN).
• Everest said that Nefecon is the second product and the first non-oncology product included in MFDS' GIFT program. Inclusion in the program is expected to accelerate regulatory review time by 25% and allow for rolling review.
• South Korea's MFDS also granted orphan drug designation status for Nefecon in November 2022, according to the company.
• Everest has a license agreement with Sweden's Calliditas, under which which the China-based Everest has rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan, Singapore and South Korea.
• IgA Nephropathy — a disease which occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. This leads to inflammation which can hamper the kidneys' ability to filter waste from the blood.

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