ViiV Healthcare’s Triumeq for HIV Gets CHMP Nod
Drugmaker ViiV Healthcare has moved one step closer to launching its investigational HIV combination therapy Triumeq in Europe.
The EMA’s Committee for Medicinal Products for Human Use recommended Triumeq (dolutegravir/abacavir/lamivudine) for treatment of HIV in patients ages 12 and up who weigh at least 88 pounds. The recommendation now goes before the European Commission, where a marketing authorization decision is expected in the third quarter of 2014.
Two elements of the combo drug — lamivudine and abacavir — have been on the market since 1995 and 2004, respectively. Dolutegravir received FDA approved last August, followed by the EMA in January. Abacavir and lamivudine are reverse transcriptase inhibitors that block the transcription of HIV RNA into DNA, while the integrase-inhibitor dolutegravir works by blocking the processes through which viral DNA integrates itself into human CD4 immune cells.
If approved, Triumeq would join a handful of other once-daily HIV therapies, including Gilead Sciences’ Complera (rilpivirine/tenofovir/emtricitabine) and Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir) and Truvada (emtricitabine/tenofovir disoproxil fumarate).
It is critical to offer doctors and patients treatment options that reduce the likelihood of drug resistance and/or discontinuation due to problems with tolerability, side effects and pill burden/dosing frequency, ViiV spokesman Marc Meacham said.
ViiV, which was created by GSK, Pfizer and Shionogi specifically to develop HIV drugs, submitted an NDA for Triumeq to the FDA in October 2013. That application is still under review. — Lena Freund
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.