Taysha Gene Therapies Gets Europe Orphan Drug Designation for Epilepsy Treatment
August 25 2021 - 8:00AM
Dow Jones News
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)
Copyright (c) 2021 Dow Jones & Company, Inc.
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