AZ, novel PNH drug 'Voydeya' may soon receive KOR approval
By Lee, Hye-Kyung | translator Kang, Shin-Kook
24.05.23 05:14:04
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MFDS has completed the safety¡¤efficacy review¡¦approval notification is expected soon
First-in-class oral paroxysmal nocturnal hemoglobinuria (PNH) treatment will soon be approved in South Korea.
According to the pharmaceutical industry on the 23rd, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy review of AstraZeneca Korea¡¯s 'Voydeya (danicopan)' for approval. Completing the safety and efficacy review usually indicates that the item will be approved soon.
Voydeya was designated as an Orphan Drug in South Korea last year and was also designated as a candidate for GIFT for approval review.
In April, the U.S. FDA granted approval for Voydeya as an add-on to the conventional drugs Ultomiris and Soliris.
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Lee, Hye-Kyung(hgrace7@dailypharm.com)
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