Merck & Co. Inc. said the U.S. Food and Drug Administration approved expanded use of its two drugs — Delstrigo and Pifeltro — for certain HIV-1 patients.
The Kenilworth, N.J.-based pharmaceutical giant had submitted applications to the U.S. regulator to expand Delstrigo and Pifeltro's indication. This would include HIV-1 patients with undetectable levels of the virus in their blood who are on a stable antiretroviral regimen with no prior treatment failure and no known substitutions associated with resistance to the Merck drugs.
Delstrigo is a once-daily tablet for adults infected with HIV-1 who do not exhibit resistance to the drug's main ingredients: doravirine, lamivudine and tenofovir.
Pifeltro is part of a new class of antiretroviral HIV drugs called non-nucleoside reverse transcriptase inhibitors, or NNRTIs, that bind to and block an HIV enzyme the virus uses to help replicate itself. The drug needs to be administered in combination with other antiretroviral medicines.
The FDA's expanded approval is based on a late-stage study called Drive-Shift , which showed that Delstrigo was as effective as current therapy in suppressing HIV-1 levels in patients who switched to the company's medicine.
The study evaluated Delstrigo in adults with HIV-1 infection who demonstrated virological suppression, or undetectable viral load, for at least six months on a stable antiretroviral treatment regimen.
Previously, both the drugs were approved by the regulatory body on the basis of late-stage studies called Drive-Ahead and Drive-Forward. In September, the European Medicines Agency recommended the approval of both medicines for the same indication.
