Tag Archive for: MCT8 deficiency

Egetis concludes that demonstrating treatment effects on T3 levels in MCT8-deficiency could provide a basis for marketing approval for Emcitate® in the US

Emcitate® (tiratricol) is the first potential treatment of MCT8 deficiency, a rare genetic disease with high unmet medical need and no available treatment. Egetis will host a webcast today at 15:00 CET (9:00am ET) Stockholm, Sweden, January 18, 2022 – Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) (the “Company”) today announced that in recent regulatory interactions, […]

Egetis intends to submit a marketing authorisation application for Emcitate® to the European Medicines Agency based on existing clinical data

Egetis concludes, based on recent regulatory interactions, that available Triac Trial I data together with recently published long-term data are sufficient for a Marketing Authorisation Application in Europe Having all clinical data required for regulatory submission already at hand significantly reduces the remaining risk for Emcitate Revised submission timelines will be communicated as soon as […]