Oral Suspension of Merck’s Isentress Approved

The FDA has approved Isentress for oral suspension, a pediatric formulation of Merck’s integrase inhibitor. The approval opens up Isentress, in combination with other antiretroviral (ARV) agents, for the treatment of HIV-1 infection in patients four weeks of age and older. The use of other active agents with Isentress is associated with a greater likelihood of treatment response, according to Merck.

The oral suspension may be used in patients as young as four weeks of age, weighing at least 3 kg to less than 20 kg. The safety and efficacy of Isentress have not been established in infants less than four weeks of age. Formulations of Isentress for specific populations now include oral suspension, chewable tablets and film-coated tablets. The oral suspension formulation of Isentress will be available in the U.S. during 3Q14.