Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending granting of marketing authorization for two HIV-1 medicines: DELSTRIGO, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate; and PIFELTRO (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. DELSTRIGO and PIFELTRO are currently under EMA review for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase class, lamivudine or tenofovir. These two recommendations will now be reviewed by the European Commission for marketing authorization in the European Union. Marketing authorization applications for DELSTRIGO and PIFELTRO are also under review in other countries, including Canada, Australia, and Switzerland. The CHMP positive opinion was based on findings from two pivotal, randomized, multicenter, double-blind, active controlled Phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD, evaluating the efficacy and safety of DELSTRIGO and PIFELTRO, respectively, in participants infected with HIV-1 with no prior antiretroviral treatment history. In DRIVE-AHEAD, DELSTRIGO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to efavirenz (EFV)/emtricitabine. In DRIVE-FORWARD, PIFELTRO demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to darunavir + ritonavir, each in combination with FTC/TDF or abacavir (ABC)/3TC.
