Janssen Biotech gets FDA delay for new Simponi indication

The US Food and Drug Administration has issued a Complete Response letter (CRL) to Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), relating to the firm’s supplemental Biologics License Application for already marketed arthritis drug Simponi (golimumab) seeking an expanded label in the treatment of active psoriatic arthritis, which was filed with the agency last year (The Pharma Letter November 12, 2010).

The application included data from a Phase III 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 says it intends to request an end-of-review meeting with the FDA to thoroughly understand the details of the CRL and discuss what future steps may be necessary to achieve the intended approval. The company did not clarify what the letter had requested, or if any additional trials had been called for.