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FDA Approves Merck's SNDAs For PIFELTRO And DELSTRIGO - Quick Facts

Merck (MRK), known as MSD outside the U.S. and Canada, announced Friday that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO (in combination with other antiretroviral agents) and DELSTRIGO (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection.

These patients 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 or the individual components of DELSTRIGO.

The FDA's approval of the sNDAs was based on findings from DRIVE-SHIFT, the Phase 3 randomized, international, multicenter, open-label trial evaluating a switch to DELSTRIGO in virologically suppressed participants (HIV-1 RNA <50 copies/mL) on a baseline regimen for at least six months prior to trial entry with no history of virologic failure.

PIFELTRO (doravirine, 100 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral agents.

DELSTRIGO is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg).

DELSTRIGO and PIFELTRO do not cure HIV-1 infection or AIDS. Both were approved in the U.S. on August 30, 2018 for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history.

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