Response Letter for SI-6603
Seikagaku Corporation announced that it has received from the FDA a complete response letter concerning Seikagaku’s biologics license application (BLA) in the U.S. for SI 6603 (generic name: condoliase), a treatment that reduces leg pain associated with lumbar disc herniation
No concerns about the clinical study results, including the efficacy and safety of SI 6603, were expressed by the FDA, and no additional clinical studies are required. However, additional observations were made, mainly concerning manufacturing facility, control of drug substance and drug product.
Seikagaku will now work closely with the FDA and Ferring Pharmaceuticals, which has concluded a license agreement for SI 6603 with Seikagaku, and consider a prompt resubmission in preparation for regulatory approval. Seikagaku is currently assessing the effect of this matter on the forecast of consolidated financial results for the fiscal year ending March 31, 2025 and will promptly disclose any matters requiring disclosure should they arise.
This is the first therapeutic agent in Japan with intradiscal administration. It does not require a general anesthesia and is less invasive to the patient than surgical treatment. Seikagaku obtained New Drug Application (“NDA”) approval for the agent in Japan on March 23, 2018, and Kaken distributes it in Japan
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.