Simponi golimumab regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Simponi golimumab from Johnson & Johnson and Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.) in combination with methotrexate to treat rheumatoid arthritis in adults who have an inadequate response to previous DMARD therapy. The recommendation is contingent on a patient access scheme in which Merck provides both the 50 and 100 mg doses of Simponi at the price of the lower dose. In October, NICE issued a preliminary appraisal requesting additional information.

NICE already recommends the use of Simponi to treat active and progressive psoriatic arthritis in adults who have an inadequate response to previous DMARD therapy (see BioCentury, May 2). The human mAb against tumor necrosis factor (TNF) alpha is approved to treat moderate to severe RA, psoriatic arthritis and ankylosing spondylitis. J&J licensed UltiMAb technology to develop Simponi from Medarex Inc., which was acquired by Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.). ...