FDA gives nod to 50th and 51st PEPFAR drugs

The US Food and Drug Administration has granted tentative approval for nevirapine tablets, indicated for use with other antiretroviral agents for the treatment of HIV-1 infection, and for the pediatric triple fixed-dose combination tablet of lamivudine, stavudine and nevirapine, the first fixed dose anti-HIV product designed to treat children under the age of 12 years.

These two drugs are the 50th and 51st AIDS treatments approved or tentatively approved for purchase under the President's Emergency Plan for AIDS Relief, a five-year, $15.0 billion effort to fight the HIV/AIDS pandemic around the world.

The fixed-dose combination comprises a complete HIV regimen taken twice daily and can be used once patients have tolerated 14 days of lead-in treatment with nevirapine taken once daily. The tablet combination can also be dissolved in water for children who cannot swallow tablets. The fact that all three drugs are combined in one tablet and that this can be stored, distributed, and administered easily to children is a significant advance in the treatment of children infected with HIV in PEPFAR countries.