Merck receives positive CHMP opinion recommending approval of Isentress 600mg
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of ISENTRESS 600 mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. In adults and pediatric patients, the recommended dosage is 1,200 mg once daily for treatment-naive patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second half of 2017. The once daily formulation of ISENTRESS is currently under review in the United States by the Food and Drug Administration. The CHMP positive opinion was based on findings from the ONCEMRK trial, an ongoing Phase 3 multicenter, double-blind, randomized, active comparator-controlled clinical trial designed to evaluate the efficacy and safety of ISENTRESS 1200 mg, given as two 600 mg oral tablets once daily, compared to ISENTRESS 400 mg twice daily, each in combination with emtricitabine + tenofovir disoproxil fumarate in previously untreated HIV-1 infected adults. Once-daily ISENTRESS 600 mg, when used as part of an HIV-1 treatment regimen, demonstrated comparable efficacy and safety to ISENTRESS 400 mg twice a day after 48-weeks of treatment across a variety of patient populations.