Merck's Isentress gets EU nod for HIV label expansion
This article was originally published in Scrip
The EU's CHMP has recommended that Merck & Co's HIV integrase inhibitor Isentress (raltegravir) be granted a label expansion to include treatment-naïve patients.
Isentress is already indicated for treatment-experienced patients.
This month, Isentress – the only approved drug in its class – was also approved for treatment-naïve patients in the US (scripnews.com, July 13th, 2009).
The supplemental approval is based on a multicentre, double-blind, active-controlled Phase III non-inferiority trial enrolling 563 treatment-naïve HIV-infected patients, known as STARTMRK (scripnews.com, July 13th, 2009).
The patients were randomised to receive Isentress or Bristol-Myers Squibb's NNRTI Sustiva (efavirenz – a standard of care), which were taken in combination with tenofovir/emtricitabine.
The proportion of patients with HIV RNA of <50 copies/ml="" was="" 87%="" for="" the="" isentress="" group="" compared="" with="" 82%="" for="" the="" sustiva="" group.="">
Other integrase inhibitors in development include Japan Tobacco/Gilead Sciences' elvitegravir, which is in Phase III, and Shionogi/GlaxoSmithKline's GSK-1349572 and GSK-1265744, which are both in Phase II.