Egetis Therapeutics AB (publ) announced that it has received a conditional acceptance from the US Food and Drug Administration (FDA) for the use of the brand name Emcitate® in the US. The company has earlier received the corresponding support from the European Medicines Agency for the use of Emcitate as the brand name in Europe. This is the best possible outcome towards securing a global brand name and the final approval process for the proprietary name Emcitate will be linked to the regulatory submission in the respective markets.

Egetis Therapeutics intends to submit a New Drug Application (NDA) in the US for Emcitate for the treatment of monocarboxylate transporter 8 (MCT8) deficiency mid-2023 under the granted Fast Track Designation.