The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Edurant® (rilpivirine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Edurant® (25mg), if approved, will be available as a once-daily treatment in combination with other antiretroviral agents (ARVs) in treatment-naïve adult patients with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
Rilpivirine is in the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
The CHMP’s positive opinion was based on 48-week analyses of ECHO and THRIVE, two Phase 3 clinical trials, which evaluated the efficacy, safety and tolerability of rilpivirine in more than 1,350 treatment-naïve HIV-1 adult patients in over 20 countries.
The 48-week analyses of both ECHO and THRIVE were published in the 16th July 2011 edition of the Lancet.
Rilpivirine is also combined with Truvade® (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) in a once-daily single-tablet regimen, which was submitted under a separate Marketing Authorisation Application (MAA) and is currently under assessment by the EMA.
The CHMP positive opinion will now be considered by the European Commission.
Rilpivirine was approved by the US Food and Drug Administration (FDA) in May 2011 and by the Canadian Health authorities (Health Canada) in July 2011.
Applications for approval have also been submitted in other countries, including Switzerland and Australia.
A fixed dose combination of rilpivirine and Truvada® (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg), was also approved by the FDA in August 2011.