20 September 2018 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending granting of marketing authorisation 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 (TDF, 300 mg); and Pifeltro (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor to be administered in combination with other anti-retroviral 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 authorisation in the European Union. Marketing authorisation 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.

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