Egetis announces EMA validation of Marketing Authorisation Application for Emcitate for the treatment of MCT8 deficiency
October 27, 2023
Stockholm, Sweden, October 27, 2023. Egetis Therapeutics AB (publ) (“Egetis” or the “Company”) (Nasdaq Stockholm: EGTX), today announced that its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Emcitate (tiratricol) for the treatment of MCT8 deficiency has been validated. On October 9, 2023, Egetis announced the submission of the MAA. EMA performs a validation of the applications it receives. The objective is to make sure all essential regulatory elements required for scientific assessment are included in the application prior to the start of the review procedure. The Emcitate MAA is as of October 26, 2023, under review by the Committee for Medicinal Products for Human Use (CHMP).