Posted by Michael Wonder on 30 Nov 2017
Merck receives FDA approval for Isentress (raltegravir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection in newborns weighing at least 2 kg
29 November 2017 - Only integrase inhibitor approved in the United States for treatment of HIV-1 in newborns from birth to 4 weeks of age.
Merck today announced that the U.S. FDA has approved Isentress (raltegravir), the company’s integrase inhibitor, for use in combination with other antiretroviral agents, for the treatment of HIV-1 in neonates – newborn patients from birth to four weeks of age – weighing at least 2 kg.
The FDA approval for the use of Isentress in the treatment of HIV-1 in neonates is supported by results from an open-label, multicenter clinical study, IMPAACT P1110, evaluating the safety and pharmacokinetics of ISENTRESS for oral suspension in 42 full-term HIV-1 exposed newborns at high risk for acquiring HIV-1 infection from their mothers.
