Investigational drug for treatment of HIV-1 infection in adults filed with FDA.
Merck Inc announced that the FDA has accepted for review two New Drug Applications (NDAs) for MK 1439 (doravirine), the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. The NDAs include data for doravirine (DOR) as a once-daily tablet for use in combination with other antiretroviral agents, and for use of doravirine with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in a once-daily fixed-dose combination single tablet as a complete regimen (DOR/3TC/TDF). The FDA has set a target action date of Oct. 23, 2018, for both applications under the Prescription Drug User Fee Act (PDUFA).
The NDAs are based upon the findings at Week 48 of two ongoing Phase III trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating the efficacy and safety of doravirine and the fixed-dose combination regimen of DOR/3TC/TDF, respectively. These data were previously presented at CROI-2017 and IAS 2017, respectively.
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