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  • AZ, novel PNH drug 'Voydeya' may soon receive KOR approval
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | May 23, 2024 05:48am
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.

Utomiris and Soliris are among AstraZeneca's bestsellers
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