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FDA Accepts Supplemental NDAs for Two HIV Treatments

The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Applications (sNDAs) for doravirine (Pifeltro) and doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) for review. The sNDAs will seek approval for the use of doravirine and doravirine/lamivudine/tenofovir disoproxil fumarate in individuals with HIV-1 whose virus is suppressed and are switching from a stable antiretroviral regimen.

The Merck therapy applications were granted FDA consideration on Tuesday, supported by the results of the phase 3 DRIVE-SHIFT non-inferior efficacy trial.

Doravirine, a 100 mg, once-daily, non-nucleoside reverse transcriptase inhibitor (NNRTI), and doravirine/lamivudine/tenofovir disoproxil fumarate, a once-daily fixed-dose combination tablet of 100 mg doravirine, 3TC/300 mg lamivudine, and TDF/300 mg tenofovir disoproxil fumarate, were first approved by the FDA as therapies for adult patients with HIV-1 previously untreated with ART in August 2018.

The pair were initially approved based on the results of the pivotal, randomized, multicenter, double-blind active controlled phase 3 DRIVE-AHEAD and DRIVE-FORWARD trials. In DRIVE-AHEAD, patients administered doravirine/lamivudine/tenofovir disoproxil fumarate once daily reported non-inferior efficacy to patients administered efavirenz/emtricitabine/tenofovir disoproxil fumarate in sustained viral suppression through 48 weeks. A greater rate of patients with high viral load at baseline treated with doravirine/lamivudine/tenofovir disoproxil fumarate reported viral suppression (77%) than the comparative group (72%).

In DRIVE-FORWARD, patients administered doravirine in combination with either emtricitabine or abacavir once daily reported non-inferior efficacy to patients administered darunavir plus ritonavir in combination with emtricitabine or abacavir, as well as a similar rate of high-viral load patients to reach suppression at 48 weeks (77% vs 74%).

The pair’s sNDA consideration will be supported by the results of the DRIVE-SHIFT trial, however. The results—presented at IDWeek 2018 in San Francisco, CA—showed the non-inferior efficacy of doravirine/lamivudine/tenofovir disoproxil fumarate, as a switch of therapy compared to continued baseline regimen of 2 NRTIs plus a boosted protease inhibitor, boosted elvitegravir, or NNRTI.

Michael Robertson, MD, executive director and section head for HIV and hepatitis C virus (HCV) at Merck Research Laboratories, noted the company’s clinical development program continues to generate “meaningful evidence for Pifeltro and Delstrigo in people living with HIV.”

“We are pleased that the FDA has accepted these supplemental new drug applications,” Robertson said in a statement. “We look forward to continuing our work with the goal of expanding HIV treatment options.”

The PDUFA date for the sNDAs is September 20, 2019.

The article “FDA To Consider Pifeltro, Delstrigo as HIV Switch-On Therapies,” was originally published on

Editors Note: Updated 1/24/2019 at 11:44 AM EST.
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