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Johnson & Johnson's Janssen Biotech unit announced Friday the receipt of a complete response letter from US regulators regarding the company's filing for expanded approval of Simponi (golimumab) for limiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.

The drugmaker, which submitted the marketing application in September last year, said it "intends to request an end-of-review meeting with the agency to thoroughly understand the details" of the letter and determine future steps. "We look forward to collaborating with the FDA to fully understand the requirements needed to support this proposed label expansion," commented Jerome A. Boscia, head of immunology development at the company's Centocor R&D division.

Simponi, which is sold by Merck & Co. in Europe, Russia and Turkey, is approved in the US to treat psoriatic arthritis, ankylosing spondylitis and, in combination with methotrexate, for patients with moderate to severe rheumatoid arthritis. The drug had annual sales of $226 million last year.

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