Janssen-Cilag International NV (Janssen) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Edurant (rilpivirine) in the European Union, 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.
Rilpivirine is already approved in Europe for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adult patients with a viral load =100,000 HIV RNA copies/ml. If approved by the European Commission, rilpivirine will become available for the first time for the treatment of adolescents with HIV-1, ages 12 to <18 years. It is estimated that one in seven of all new HIV infections occur in adolescence and young adulthood.
"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 rilpivirine 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 were most recently presented at the International AIDS Society Conference in Vancouver this year (IAS 2015) and showed that at week 48, 26/36 (72 per cent) patients overall achieved virologic response (HIV-1 RNA < 50 copies/ml). Adverse events considered at least possibly related to rilpivirine occurred in 13 (36 per cent [CI: 21 per cent – 54 per cent]) patients, mainly (excluding investigations) somnolence (n=5, 14 per cent [CI: 5 per cent – 30 per cent]) and nausea (n=2, 6 per cent [CI: 1 per cent – 19 per cent]). Overall, the data support the use of rilpivirine 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.
As of 2012, it is estimated that 35 million people are currently living with HIV globally, including 2.1 million adolescents, many of whom were born with the virus. While the number of HIV-related deaths among adults is decreasing, deaths among adolescents are increasing, especially in HIV epidemic areas. In 2012, UNAIDS and WHO estimate that 2.2 million people were living with HIV in the WHO European Region, including 1.3 million in eastern Europe and central Asia.
Rilpivirine is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adult patients with a viral load = 100,000 HIV RNA copies/ml. Rilpivirine first received initial marketing authorisation in Europe in 2011.