Complete Response on Lumbar Disc Herniation BLA

FDA has issued Japan-based Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar disc herniation. The company says the letter did not cite any clinical study-related efficacy or safety information, and no additional clinical studies are required. However, observations were made about the manufacturing facility, and control of drug substance and drug product. Seikagaku says it will work closely with the agency and its partner, Ferring Pharmaceuticals, to address the issues and prepare a “prompt” resubmission for regulatory approval.

Condoliase is described by the company as a mucopolysaccharidase enzyme that works by breaking down the glycosaminoglycans in the nucleus pulposus (the soft, jelly-like center of the intervertebral disc). This reduces the size of the herniation and relieves pressure on the nerve roots, which can cause pain and numbness, it says.