Simponi golimumab regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against Simponi golimumab from Johnson & Johnson and Merck to treat active and progressive psoriatic arthritis in adults who have an inadequate response to previous DMARD therapy. NICE said Simponi was clinically effective vs. placebo, but not as effective as the key comparator, Enbrel etanercept, based on a mixed treatment comparison. The agency also said Simponi's incremental cost-effectiveness ratio (ICER) would likely be higher than the company's estimate if the estimate included the cost of a 100 mg dose, the recommended dose for patients who weigh more than 100 kg. The appraisal also noted that there was uncertainty in the long-term adverse event profile of the drug. Comments are due by Oct. 27, with a second appraisal committee meeting scheduled for Nov. 10. ...