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Merck: CHMP Adopts Positive Opinion For Isentress 600 Mg In EU

Merck & Co. Inc. (MRK) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion recommending approval of Isentress, or raltegravir 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 (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of Isentress 400 mg twice daily.

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.

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 U.S. by the Food and Drug Administration.

by RTT Staff Writer

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