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Merck Says FDA Accepts For Review Two NDAs For Doravirine - Quick Facts

Merck & Co. Inc. (MRK) said that the U.S. Food and Drug Administration has accepted for review two New Drug Applications or NDAs for 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 or 3TC, and tenofovir disoproxil fumarate or TDF in a once-daily fixed-dose combination single tablet as a complete regimen (DOR/3TC/TDF).

Merck noted that the FDA has set a target action date of October 23, 2018, for both applications under the Prescription Drug User Fee Act or PDUFA.

The NDAs are based upon the findings at Week 48 of two ongoing Phase 3 trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating the efficacy and safety of doravirine and the fixed-dose combination regimen of DOR/3TC/TDF, respectively.

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