Janssen’s Edurant recommended for EU approval in adolescents

Janssen has announced that its HIV therapy Edurant has been recommended for EU approval as a treatment for adolescent patients.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on extending the drug's indication to include patients aged 12 to 18 years with HIV-1 infections.

Edurant is already approved in Europe for the treatment of HIV-1 infection, in combination with other antiretroviral agents, in treatment-naive adult patients. Recent clinical trials have shown to can also be beneficial for adolescent patients.

It is estimated that one in seven of all new HIV infections occur in adolescence and young adulthood, with HIV-related diseases on the rise in this age group.

Dr Christiane Moecklinghoff, medical director for virology at Janssen, said: "We look forward to the European Commission's decision and the opportunity to offer an additional treatment option to adolescent patients."

This comes after the company's multiple myeloma therapy daratumumab was accepted for accelerated regulatory review by the CHMP earlier this month.