Dailypharm Live Search Close

Marketing authorization imminent for Obizur in Korea

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.03.16 12:00:00

°¡³ª´Ù¶ó 0
MFDS completes safety and efficacy review for the drug...received orphan designation in 2021



Marketing authorization for Takeda Pharmaceuticals Korea¡¯s ¡®Obizur Inj (susoctocog alfa)¡¯ is imminent in Korea. Obizur Inj is a treatment for bleeding episodes in adults with acquired hemophilia A.

The drug has been used as a treatment for hemophilia A in Korea after receiving an orphan drug designation in July 2021.

According to the industry on the 16th, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Obizur. If the MFDS completed the safety and efficacy review without issues, the drug¡¯s marketing authorization is expected to be underway soon.

Hemophilia is a congenital bleeding disorder caused by a congenital deficiency of

Lee, Hye-Kyung(hgrace7@dailypharm.com)
If you want to see the full article, please JOIN US (click)