WEDNESDAY, SEPTEMBER 28, 2016

Merck receives FDA approval for pediatric HIV treatment

Merck, a global healthcare company, announced the U.S. approval on Wednesday of ISENTRESS, a new pediatric formulation of the company's integrase inhibitor to be used for the treatment of HIV-1 infection.

The U.S. Food and Drug Administration approved ISENTRESS in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older. Merck said the use of other active agents with ISENTRESS is associated with a higher likelihood of treatment response.

"We are very pleased that ISENTRESS can now be a part of a treatment regimen for HIV-1 infected infants and children as young as four weeks of age," Hedy Teppler, the executive director for clinical research at Merck Research Laboratories, said.

The oral suspension may be used in patients as young as four weeks of age who weigh between 6.6 pounds and 44.1 pounds. The efficacy and safety of ISENTRESS is not established in children under the age of four weeks. ISENTRESS formulations currently include oral suspension, film-coated tablets and chewable tablets.

ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA, keeping the virus from replicating and infecting new cells.

Merck anticipates the oral suspension formulation will become available in the U.S. during 2014's third quarter.