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 infection. Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.
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 US 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.
The approval from the European Commission was based on data from two pivotal, randomised, 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% of the participants were based in Europe (379/1494).
In DRIVE-AHEAD, Delstrigo met its primary endpoint, demonstrating non-inferior efficacy compared to efavirenz /emtricitabine /tenofovir disoproxil fumarate at 48 weeks (84% in the Delstrigo group achieved viral suppression of HIV-1 RNA
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial