Egetis secures conditional acceptance for Emcitate® as brand name in the US
January 26, 2022
Stockholm, Sweden, January 26, 2022 – Egetis Therapeutics AB (publ) (Nasdaq Stockholm: EGTX) today 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.
“I am delighted that our pre-launch preparations run according to plan. It is very positive that also the FDA supports the brand name Emcitate since it is advantageous to have the same name globally. In this setting it is important to stress that we, in compliance with pharma legislations, will not promote Emcitate until marketing authorizations have been granted. However, there are other initiatives that we run already now with the aim to improve the situation for those affected by MCT8 deficiency,” said Henrik Krook, VP Commercial Operations at Egetis Therapeutics.
“Our disease awareness initiatives will hopefully contribute to that more physicians understand how to diagnose and manage MCT8 deficiency. Starting this year, we will arrange disease awareness activities in connection with international congresses in neurology and endocrinology on top of an expanding digital presence through channels such as our already established platform www.mct8deficiency.com”, he continued.
One of the disease awareness initiatives that the company launched 2021, the MCT8 deficiency focused “Cuddly toy campaign”, has been shortlisted at the prestigious Pharmaceutical Marketing Society awards in the category of best health care professional disease awareness campaign. The awards ceremony will be held in London March 2022.