Orchard Therapeutics’ Biologics License Application for OTL-200, a gene therapy under investigation for metachromatic leukodystrophy treatment, has been accepted by the FDA. This rare disease treatment received approval in Europe back in 2020. Notably, the FDA has granted Orchard’s application Priority Review status, reducing the typical regulatory review timeline from 10 months to just six. We can expect the FDA’s decision on March 18, 2024.
“Today marks another significant milestone for patients and their families in the U.S. grappling with this devastating and heart-wrenching disease. They’ve endured an unimaginable journey, navigating the diagnostic challenges...
