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, the US Food and Drug Administration (FDA) acknowledges that demonstrating a treatment effect on thyroid hormone T3 levels and the manifestations of chronic thyrotoxicosis could provide a basis for marketing approval also in the US. Consequently, the Company now has an aligned regulatory strategy for EU and US. The Company intends to submit a New Drug Application (NDA) in the US for Emcitate® (tiratricol) for the treatment of monocarboxylate transporter 8 (MCT8) deficiency in mid-2023 under the Fast Track Designation granted by the FDA in October 2021. This follows the announcement in December 2021 of intention to submit the Marketing Authorisation Application (MAA) for Emcitate to the European Medicines Agency (EMA) based on existing clinical data on the manifestations of chronic thyrotoxicosis in MCT8 deficiency.
