Janssen gains positive CHMP recommendation for EDURANT
The CHMP based its recommendation on a review that involved data from a 48-week, multi-center, Phase 2 study. It evaluated the safety, tolerability, pharmacokinetics and efficacy of EDURANT.
The recommendation changes the terms of EDURANT’s marketing authorization within the E.U. Now, the treatment can be administered to HIV patients who are between the ages of 12 and 19 years old.
EDURANT, or rilpivirine, has already received approval throughout Europe to be used as treatment for HIV-1 infections. According to this approval, the drug must be combined with other antiretroviral treatments for antiretroviral treatment-naïve patients who are adults.
"In some regions, adolescents are an age group for whom HIV-related diseases are on the rise, as young people can be overlooked or face barriers when accessing health services. We are happy to be closer to improving the health needs of this vulnerable patient group," Janssen Medical Director for Virology Christiane Moecklinghoff said. "We look forward to the European Commission's decision and the opportunity to offer an additional treatment option to adolescent patients."