The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection, starting treatment for the first time and with a viral load ≤ 100,000 HIV-1 ribonucleic acid (RNA) copies/ml at start of treatment.
Edurant is already approved in Europe for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-na？ve adult patients with a viral load ≤100,000 HIV RNA copies/mL. If approved by the European Commission, Edurant will become available for the treatment of adolescents with HIV-1 for the first time. It is estimated that one in seven of all new HIV infections occur in adolescence and young adulthood.
CHMP opinion based on a Phase 2 study of Edurant in adolescents with HIV-1 infection
“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,” said Christiane Moecklinghoff, M.D Ph.D., Medical Director, Virology, Janssen EMEA. “We look forward to the European Commission’s decision and the opportunity to offer an additional treatment option to adolescent patients.”
The CHMP adopted the opinion based on a review of 48-week data from a Phase 2 multi-centre study, which looked at the pharmacokinetics, safety/tolerability and efficacy of Edurant 25 mg once daily in combination with a background regimen of antiretroviral treatment in HIV-1 infected adolescents aged 12 to <18 years and starting treatment for the first time.
Updated results from the study showed that at week 48, 72% patients overall achieved virologic response (HIV-1 RNA < 50 copies/mL). Adverse events considered at least possibly related to Edurant occurred in 36% patients, mainly somnolence and nausea. Overall, the data support the use of Edurant combined with other antiretrovirals in adolescent patients aged 12 to <18 years with HIV-1 infection, starting treatment for the first time and who have a viral load ≤ 100,000 HIV-1 RNA copies/mL at start of treatment, with pharmacokinetic results similar to those observed in adults.