EU CHMP recommends extending approval of Edurant (rilpivirine) in HIV to patients aged 12 and older- Janssen Therapeutics

The EU's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Edurant (rilpivirine), from Janssen Therapeutics in HIV treatment, allowing treatment of patients aged 12 and older. The new indication is for the treatment of HIV type 1 infection in antiretroviral treatment-naïve adult patients 12 years of age and older with a viral load of at least 100,000 HIV-1 RNA copies/ml.