European Commission Approves Merck’s DELSTRIGO

by firstwordpharma

November 29, 2018

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Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved DELSTRIGO™ and PIFELTRO™ for the treatment of HIV-1 infection. DELSTRIGO is a new once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg^[1]). It is indicated in the European Union for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of antiviral agents, lamivudine or tenofovir.PIFELTRO (doravirine, 100 mg) is a new, once-daily NNRTI indicated (in the EU) in combination with other antiretroviral medicines for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the NNRTI class.

In the United States, both DELSTRIGO and PIFELTRO are indicated for the treatment of HIV-1 infection in adults 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.

"We are very pleased that the European Commission has approved DELSTRIGO and PIFELTRO, as this approval marks another important milestone in Merck's unwavering commitment to the global HIV community," said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, Global Clinical Development, Merck Research Laboratories. "These medicines bring new treatment options with demonstrated efficacy that could potentially address unmet needs for people in Europe living with HIV."

The approval allows for marketing of DELSTRIGO and PIFELTRO in all 28 European Union member states, plus Iceland, Lichtenstein and Norway, and follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency announced on Sept. 20, 2018. Marketing authorization applications for DELSTRIGO and PIFELTRO are also under review in other countries, including Australia and Switzerland. The U.S. Food and Drug Administration approved DELSTRIGO and PIFELTRO on Aug. 30, 2018. Health Canada approved PIFELTRO on Oct. 12, 2018 and DELSTRIGO on Nov. 9, 2018. Availability for DELSTRIGO and PIFELTRO in the EU is anticipated to begin in the first half of 2019.

"As a practitioner serving people living with HIV, I welcome new medicines that can help us tailor HIV treatment regimens to the needs of the individual," said Dr. Esteban Martínez, senior consultant and associate professor of medicine, infectious diseases, University of Barcelona, Spain. "The approvals of DELSTRIGO and PIFELTRO bring important new treatment options to market which have shown demonstrated efficacy and low rates of discontinuation."

Data Supporting the Approvals of DELSTRIGO and PIFELTRO in the European Union

The approval from the European Commission was based on data 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. Across both of the studies, 25.4 percent of the participants were based in Europe (379/1494).

In DRIVE-AHEAD, DELSTRIGO met its primary endpoint, demonstrating non-inferior efficacy compared to efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) at 48 weeks (84% in the DELSTRIGO group achieved viral suppression of HIV-1 RNA <40 copies/mL vs. 80% in the EFV/FTC/TDF group; treatment difference: 4.1%, 95% confidence interval: -1.5, 9.7). The Week 96 data were supportive of the Week 48 findings. At Week 96, 76% in the DELSTRIGO group achieved viral suppression of HIV-1 RNA <40 copies/mL vs. 73% in the EFV/FTC/TDF group; treatment difference: 3.3%, 95% confidence interval: -3.1, 9.6. The rate of discontinuation of treatment due to adverse events was lower in the DELSTRIGO treatment group than in the EFV/FTC/TDF treatment group, 3% and 6.6% respectively. Clinical adverse reactions of ...