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 all parts of the regulatory dossier are confirmed
- Egetis will host a webcast today at 15:00 CET (9:00 am ET)
Stockholm, Sweden, December 13, 2021 – Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today announced that after a pre-submission meeting held last week with concerned European regulatory agencies (EMA’s Rapporteur and Co-Rapporteur), the Company concludes that the clinical data from the Triac Trial I (Groeneweg et al. 2019), together with the data from long-term treatment with Emcitate (tiratricol) for up to six years in 67 patients (van Geest et al. 2021) will be sufficient for a regulatory review of a Marketing Authorisation Application (MAA) to the European Medicines Agency for the treatment of monocarboxylate transporter 8 (MCT8) deficiency. Thus, all clinical data necessary for regulatory submission is already available. The ongoing Triac Trial II will continue to further establish the effects of early intervention on the neurocognitive development aspects of the disease.