The Food and Drug Administration (FDA) has accepted two new drug applications Merck submitted for an investigational treatment aimed at ameliorating HIV-1 infection in adults, according to a company press release.
Doravirine, Merck’s non-nucleoside reverse transcriptase inhibitor (NNRTI), underwent clinical Phase 3 trials, producing results sufficient to earn the FDA’s approval. The treatment includes a once-daily tablet with additional antiretroviral agents, the release said.
An alternative format consists of one complete regimen: a single combination tablet made up of lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) in addition to the doravirine. The various laboratory combinations were named Drive-Forward, Drive-Ahead and Drive-Shift.
“Since the earliest days of the epidemic, Merck has sustained our commitment to research and meeting the needs of people living with HIV,” Dr. George Hanna, associate vice president for global clinical development at Merck Research Laboratories, said in the release. “Doravirine was engineered by our research team to provide a meaningful new treatment approach and address unmet medical needs in the treatment of HIV-1 infection.”
Merck, based in Kenilworth, New Jersey, focuses on treatments for the world’s most challenging diseases.
“We have been pleased with the clinical findings to date and look forward to working with the FDA as it reviews our applications," Hanna said.