FDA slaps CRL on Seikagaku’s BLA for condoliase

Japanese drugmaker Seikagaku Corporation (TYO: 4548) announced that it has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning Seikagaku’s biologics license application (BLA) for SI-6603 (condoliase), a treatment that reduces leg pain associated with lumbar disc herniation.

The company noted that 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 the manufacturing facility, control of drug substance and drug product.

Seikagaku will now work closely with the FDA and Switzerland-based Ferring Pharmaceuticals, which concluded a global (excluding Japan) license agreement for SI-6603 with Seikagaku in 2016, and consider a prompt resubmission in preparation for regulatory approval.