CRL issued for Seikagaku's condoliase (SI-6603) BLA in lumbar disc herniation
- Sponsor
- Seikagaku Corporation
- Drug
- condoliase
- Indication
- radicular leg pain associated with lumbar disc herniation
FDA issued a second Complete Response Letter for Seikagaku's condoliase (SI-6603) BLA in lumbar disc herniation, citing cGMP deficiencies at both drug-substance and drug-product facilities.
What this means
A herniated lumbar disc can press on a spinal nerve and cause severe radiating leg pain (sciatica) that steroid injections cannot resolve and that often ends in surgery. Condoliase is a single injection into the disc of a bacterial enzyme that shrinks the disc from within by breaking down its cushioning material, easing pressure on the nerve. It has been used in Japan since 2018 as Hernicore. Seikagaku sought US approval as SI-6603 and had received a Complete Response Letter in a prior review cycle; on Sept 10 the FDA issued a second CRL on the resubmitted BLA (filed March 2026). The reason is entirely manufacturing: deficiencies from the drug-substance facility inspection have not been fully resolved, and the FDA's newly conducted cGMP inspection of the drug-product contract manufacturer identified additional deficiencies. The FDA raised no concerns about the clinical study results (efficacy or safety) and did not ask for any additional clinical trials. Seikagaku says it will work with the FDA and its US licensee Ferring Pharmaceuticals toward a prompt resubmission.