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FDA Accepts New Drug Application for Raltegravir/Lamivudine Combo for HIV Patients

Drug would be used with other antiretroviral agents

A new drug application for a fixed-dose combination of raltegravir and lamivudine for the treatment of HIV-1 infection has been accepted for standard review by the FDA.

The combo’s developer (Merck) is seeking approval for raltegravir 300 mg/lamivudine 150 mg, in combination with other antiretroviral agents, for the treatment of human immunodeficiency virus-1 (HIV-1) infection 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 U.S. Several different formulations of the drug are available, including a film-coated tablet (400 mg), chewable tablets (25 mg and 100 mg), and oral suspension (single-use 100-mg packet). The raltegravir/lamivudine combination contains a new formulation of raltegravir.

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 a treatment response.

Raltegravir works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.

Source: Merck; June 24, 2015.

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