FDA to Review Pifeltro, Delstrigo for Expanded HIV Indication

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. 

For more information call (800) 672-6372 or visit Merck.com.