ARTICLE | Clinical News

Edurant rilpivirine regulatory update

April 23, 2012 7:00 AM UTC

The German Institute for Quality and Efficiency in Health Care (IQWiG) issued preliminary benefit assessments of HIV drugs Edurant rilpivirine and Eviplera emtricitabine/tenofovir/rilpivirine compared with Sustiva efavirenz plus base therapy. The agency said an assessment there was a "substantial" degree of benefit for Edurant rilpivirine from Johnson & Johnson in treatment-naive patients. However, IQWiG found no additional benefit for Eviplera in a separate assessment. The agency considered the dossier for Eviplera incomplete because Gilead did not carry out a required analysis of sub-groups and excluded a relevant study.

The companies have until May 7 to respond to IQWiG's evaluations. The Federal Joint Committee (G-BA) will then review IQWiG's recommendations and issue final decisions for both drugs in early July. Pricing negotiations would begin after G-BA's final assessment. ...