FDAnews Drug Daily Bulletin

Merck Receives FDA Approval of Isentress HD in Combination with Other Antiretroviral Agents

June 2, 2017

The FDA approved a 1200 mg once-daily dose of Merck’s integrase inhibitor Isentress HD.

The drug is to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of Isentress 400 mg given twice daily.

Results from a Phase III clinical trial showed viral suppression at week 48, 89 percent of treatment-naïve HIV-1 infected patients receiving Isentress HD 1200 mg once a day.

Merck anticipates Isentress HD making the dose available to pharmacies in approximately four weeks.

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