Pifeltro Approval History
FDA Approved: Yes (First approved August 30, 2018)
Brand name: Pifeltro
Generic name: doravirine
Dosage form: Tablets
Treatment for: HIV Infection
Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection.
Pifeltro is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients:
- with no prior antiretroviral treatment history, OR
- to replace the current antiretroviral regimen in those who 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 doravirine.
Development History and FDA Approval Process for Pifeltro
|Sep 20, 2019|| Merck’s Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed|
|Aug 30, 2018|| FDA Approves Merck’s Pifeltro (doravirine) for the Treatment of HIV-1 in Appropriate Patients|
|Jul 24, 2018||Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine|
|Jan 8, 2018||FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection|
|Feb 14, 2017||Merck’s Doravirine, an Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) for the Treatment of HIV-1 Infection, Met Primary Efficacy Endpoint in Pivotal Phase 3 Trial|
|Nov 3, 2014||Merck Announces Data from 48-Week Phase 2b Study of Investigational HIV Therapy Doravirine (MK-1439) in Treatment-Naive Patients|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.