Simponi golimumab regulatory update

The U.K.'s NICE issued final guidance recommending Simponi golimumab from Johnson & Johnson and Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.) to treat active and progressive psoriatic 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 to the NHS at the price of the lower dose. The guidance is in line with a March final appraisal determination (FAD) for the human mAb against tumor necrosis factor (TNF) alpha (see BioCentury, March 21).

Simponi is approved in the EU to treat moderate to severe rheumatoid arthritis (RA), active and progressive psoriatic arthritis, and severe active 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.). ...