By Chris Wack

 

Taysha Gene Therapies Inc. said it has been granted orphan drug designation from the European Commission for TSHA-105, an AAV9-based gene therapy in development for SLC13A5-related epilepsy.

Taysha said the designation supports an unmet need for treatment options for patients with rare form of genetic epilepsy, and TSHA-105 is first program in its pipeline to receive orphan drug designation from European Commission.

The European Commission grants orphan drug designation for medicines being developed for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect fewer than 5 in 10,000 people in the European Union. Orphan designation in the European Union includes benefits such as protocol assistance, reduced regulatory fees and market exclusivity.

TSHA-105 has already been granted orphan drug designation by the U.S. Food and Drug Administration.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

August 25, 2021 07:50 ET (11:50 GMT)

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