FDA AS Diberi Kajian Keutamaan Untuk Krim Opzelura Inhibitor JAK Topikal

Incyte recently announced that the U.S. Food and Drug Administration (FDA) has accepted Opzelura (ruxolitinib, 1.5% cream) supplementary new drug application (sNDA) and granted priority review: the drug is a non-steroidal, anti-inflammatory, Topical JAK inhibitors for the treatment of vitiligo (vitiligo) in adults and adolescents (age> 12 years). The FDA has designated the sNDA's "Prescription Drug User Charges Act (PDUFA)" target date as April 18, 2022. In October of this year, the European Medicines Agency (EMA) accepted Opzelura's marketing authorization application (MAA) and has initiated a formal review process: it is used for adults and adolescents (age>12 tahun) untuk merawat vitiligo bukan{1}}segmental dengan penglibatan muka .

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