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news.The US Food and Drug Administration (FDA) has issued a complete response letter to Janssen Biotech’s Simponi (golimumab) supplemental biologics license application (sBLA) seeking an expanded label in the treatment of active psoriatic arthritis.
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Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.
The drug is available either through the Simponi SmartJect autoinjector or a prefilled syringe.
The sBLA included data from a Phase 3 trial evaluating the effect of Simponi in inhibiting the progression of structural damage and maintaining improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis.
Janssen Biotech intends to request an end-of-review meeting with the FDA to thoroughly understand the details of the complete response letter and discuss what future steps may be necessary to achieve the intended approval.