FDA accepts Merck’s NDA for fixed-dose combination of Raltegravir with Lamivudine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for a fixed-dose combination (FDC) of raltegravir with lamivudine for the treatment of HIV-1 infection (MK-0518B) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck is seeking FDA approval for 150 mg lamivudine/300 mg raltegravir, in combination with other antiretroviral (ARV) agents, for the treatment of HIV-1 in adults, adolescents (16 years of age and older) and pediatric patients (6 through 16 years of age and weighing at least 30 kg).  Raltegravir is currently marketed as ISENTRESS^® in the United States. Several different formulations of ISENTRESS are currently available, including a film-coated tablet (400 mg), chewable tablets (25 mg and 100 mg) and oral suspension (single use 100-mg packet). The MK-0518B FDC contains a new formulation of raltegravir. 

“We are pleased that the FDA has accepted our application for a fixed-dose combination of raltegravir and lamivudine. This combination pairs two HIV medications and, if approved, will offer prescribers an additional option in the treatment regimens of HIV-1 patients,” said Dr. Nick Kartsonis, executive director, clinical research, Merck Research Laboratories. “This filing is another example of Merck’s commitment to HIV.”

ISENTRESS (raltegravir) is indicated in combination with other ARV agents for the treatment of HIV-1 infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.