FDA approves sNDA for Pifeltro in HIV.- Merck
Merck announced that the FDA approved supplemental New Drug Applications (sNDAs) for Pifeltro (in combination with other antiretroviral agents) that expand its indications to include adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro. Pifeltro (doravirine, 100 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral agents.
Pifeltro does not cure HIV-1 infection or AIDS. Pifeltro was approved in the United States on August 30, 2018 for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history. Pifeltro is contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of Pifeltro.
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