Tiratricol Granted Orphan Drug Designation for MCT8 Deficiency in Japan – Egetis Therapeutics

Egetis Therapeutics AB announced that its partner Fujimoto Pharmaceutical Corporation, which has an exclusive license agreement to develop and commercialize Emcitate (tiratricol) for the treatment of MCT8 deficiency in Japan, has been granted Orphan Drug Designation (ODD) for tiratricol for MCT8 deficiency by the Ministry of Health, Labour and Welfare (MHLW).

One of the benefits of ODD in Japan is that a marketing authorization application is eligible for Priority Review, reducing the review time from approximately twelve to nine months and an extension of the market exclusivity period to ten years.