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news.Janssen Biotech has received complete response letter (CRL) from the US Food and Drug Administration (FDA) for its human monoclonal antibody Simponi's (golimumab) supplemental biologics license application (sBLA).
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The company plans to call for an end-of review meeting with the FDA to comprehend the details of the CRL and to discuss regarding further steps to be taken for receiving the intended approval.
Johnson & Johnson Pharmaceutical Research & Development Centocor Research & Development division Immunology Development head, vice president Jerome Boscia said Simponi is an important once-monthly anti-tumor necrosis factor (TNF)-alpha therapy for rheumatologists in the treatment of patients with moderately to severely active rheumatoid arthritis.
"We look forward to collaborating with the FDA to fully understand the requirements needed to support this proposed label expansion," Boscia said.