FDA accepts sBLAS for Pifeltro and Delstrigo for use in HIV patients switching from a stable antiretroviral regimen. Merck Inc.

Merck has announced that the FDA has accepted for review supplemental New Drug Applications (sNDAs) for Pifeltro and Delstrigo. The applications seek approval for Pifeltro (in combination with other antiretroviral medicines) and Delstrigo for use in people living with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed (HIV-1 RNA <50 copies ml). the prescription drug user fee act (pdufa) date for the sndas is 29 september 2019.>

Pifeltro (doravirine, 100 mg), a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines, and Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) as a complete regimen, are currently indicated for the treatment of HIV-1 infection in adult patients not previously treated with antiretroviral therapy. Delstrigo contains a boxed warning regarding post-treatment acute exacerbations of hepatitis B (HBV) infection. Pifeltro and Delstrigo do not cure HIV-1 infection or AIDS.