FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

DiscGenics Grabs FDA Fast Track Designation for Cell Therapy

Aug. 30, 2019

The FDA granted fast track status for DiscGenics’ cell therapy for degenerative disc disease.

The non-invasive treatment, IDCT, is currently being evaluated in two multicenter trials in the U.S. and Japan for treating patients with mild to moderate lumbar DDD. The condition, which isn’t actually a disease, involves pain from one or more deteriorated intervertebral discs that can range from annoying to debilitating.

The company in January announced its U.S. study of the drug-biologic showed safety in the first cohort of patients, with no issues arising from first-time administration.

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