Merck announced that the Food and Drug Administration (FDA) has accepted the supplemental New Drug Applications (sNDAs) for Pifeltro (doravirine) and Delstrigo (doravirine, lamivudine, tenofovir disoproxil fumarate [TDF]) seeking approval for use in patients with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed (HIV-1 RNA <50 copies/mL).

Once-daily Pifeltro and Delstrigo were initially approved in August 2018 to treat HIV-1 infection in adults with no prior antiretroviral treatment experience. Delstrigo is approved as a complete regimen, whereas Pifeltro is to be administered in combination with other antiretrovirals.

The sNDA submissions were supported by data from the Phase 3 DRIVE-SHIFT trial (N=670) which met its primary endpoint of noninferior efficacy, as measured by the proportion of patients who switched to Delstrigo and had plasma HIV-1 RNA levels <50 copies/mL at Week 48 compared with the proportion of patients who continued on their baseline regimen (2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a boosted protease inhibitor, boosted elvitegravir, or NNRTI) and had HIV-1 RNA levels <50 copies/mL at Week 24.

The FDA has set a Prescription Drug User Fee Act (PDUFA) date of September 20, 2019 for these sNDAs. 

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