The US Food and Drug Administration (FDA) has accepted to review two new drug applications (NDAs) submitted by Merck for its investigational candidate doravirine (DOR).
DOR is a non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed to treat adults with HIV-1 infection, and is in various clinical trials as monotherapy and combination therapy.
The NDAs present data for DOR as a once-daily tablet for use with other antiretroviral agents, and for its combination with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose single tablet as a complete regimen (DOR/3TC/TDF).
Merck Research Laboratories global clinical development associate vice-president Dr George Hanna said: “Doravirine was engineered by our research team to provide a meaningful new treatment approach and address unmet medical needs in the treatment of HIV-1 infection.
“We have been pleased with the clinical findings to date and look forward to working with the FDA as it reviews our applications.”
The NDAs include results obtained at week 48 of ongoing Phase III DRIVE-FORWARD and DRIVE-AHEAD trials investigating the safety and efficacy of doravirine and fixed-dose DOR/3TC/TDF regimen.
DRIVE-FORWARD is a non-inferiority trial being performed with 100mg of doravirine in 769 treatment-naïve patients for 96 weeks, while the active comparator-controlled DRIVE-AHEAD trial involves a 100mg/300mg/300mg fixed-dose combination of DOR/3TC/TDF.
Both multi-centre, double-blind, randomised trials will be followed by an open-label extension study.