Posted by Michael Wonder on 24 Jan 2019
U.S. FDA accepts sNDAs for Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)
23 January 2019 - Potential new indication would expand use to allow treatment-experienced adults living with HIV-1 whose virus is suppressed to switch to Pifeltro (in combination with other anti-retrovirals) or Delstrigo.
Merck today announced that the U.S. FDA has accepted for review supplemental new drug applications (sNDAs) for PIifeltro 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 date for the sNDAs is 20 September 2019.
