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  • Danicopan has been designated for GIFT
  • by Eo, Yun-Ho | translator Kim, Jung-Ju | Jul 17, 2023 05:30am
The Ministry of Food and Drug Safety confirmed Danicopan as an orphan drug at the same time as an expedited review drug
Satisfaction of evaluation criteria such as hemoglobin level in phase 3 ALPHA study
Danicopan, a combination partner of Soliris, was designated as a GIFT at the same time as this orphan drug designation. The Ministry of Food and Drug Safety recently announced that AstraZeneca's Danicopan (ALXN2040) will be designated as an orphan drug and GIFT in Korea.

Danicopan, a candidate for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), has been designated as an orphan drug for PNH treatment in the United States and Europe and has been selected as a breakthrough therapy by the US FDA and as a PRIME target by the European EMA. Danicopan demonstrated efficacy as a potential complementary treatment in patients with PNH who experienced clinically significant extravascular hemolysis in the phase 3 A
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