Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting of marketing 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.
“We are pleased with the CHMP’s positive opinion recommending approval of Delstrigo and Pifeltro, which marks an important step forward in advancing new treatments for people living with HIV,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, Global Clinical Development, Merck Research Laboratories. “This represents another milestone in Merck’s more than 30-year commitment to HIV research and treatment, and advances our efforts to address the unmet needs of the HIV community worldwide.”
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 (FTC)/TDF. In Drive-Ahead, 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.
The FDA approved Delstrigo and Pifeltro on August 30, 2018. In the United States, both Delstrigo and Pifeltro are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. Delstrigo contains a boxed warning regarding post-treatment acute exacerbations of hepatitis B (HBV) infection. Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.