ARTICLE | Clinical News

Olysio simeprevir regulatory update

September 15, 2014 7:00 AM UTC

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said HCV drug Olysio simeprevir from Medivir and Johnson & Johnson's Janssen Research & Development LLC unit offers "major" additional benefit over Incivek telaprevir in patients with HCV genotype 1 infection who were non-responsive to previous treatment. IQWiG said the Phase III ATTAIN trial comparing combinations of either Olysio -- a HCV NS3/4A protease inhibitor -- or Incivek from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX, Boston, Mass.) plus peginterferon alfa and ribavirin showed that Olysio produced fewer serious side effects and premature treatment discontinuations than Incivek. The Olysio group also had fewer skin and gastrointestinal disorders.

IQWiG also said the Phase IIb PILLAR trial and the Phase III QUEST-1, QUEST-2 and PROMISE trials suggest that Olysio may increase the likelihood of sustained virologic response (SVR) in treatment-naive and relapsed patients. However, the agency said the data were "not quantifiable." A final assessment by the Federal Joint Committee (G-BA) on the extent of added benefit is expected in mid-November. Comments are due by Sept. 22. ...