Merck’s HIV Combo Treatment Advances Towards FDA Filing
Based on the search results, here are the key details about Merck's progress towards an FDA filing for their HIV therapy:
Merck announced positive topline results from two pivotal Phase 3 trials evaluating their investigational once-daily, oral, two-drug regimen of doravirine/islatravir (DOR/ISL) for treating adults with virologically suppressed HIV-1 infection 13.
The trials met their primary efficacy endpoints, demonstrating non-inferiority to baseline antiretroviral therapy and bictegravir/emtricitabine/tenofovir alafenamide in maintaining viral suppression 1314.
At 48 weeks, the DOR/ISL combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL) in virologically suppressed adults 10.
The safety profiles were generally comparable between DOR/ISL and other therapies in these trials 13.
Merck plans to present detailed findings from these trials at a future scientific congress and file the data with regulatory agencies 14.
This advances Merck's goal of offering new treatment options to help address the needs of people living with HIV 13.
Islatravir is being evaluated in multiple early and late-stage clinical trials in combination with other antiretroviral therapies for HIV-1 treatment 13.
The positive Phase 3 results position this treatment for potential regulatory submission to the FDA 6.
Sources:
6. https://www.stocktitan.net/news/MRK/merck-announces-topline-results-from-pivotal-phase-3-trials-0ass2bfqclcs.html
10. https://www.merck.com/news/gilead-and-merck-announce-phase-2-data-showing-a-treatment-switch-to-an-investigational-oral-once-weekly-combination-regimen-of-islatravir-and-lenacapavir-maintained-viral-suppression-in-adults-at-wee/
13. https://www.merck.com/news/merck-announces-topline-results-from-pivotal-phase-3-trials-evaluating-investigational-once-daily-oral-two-drug-single-tablet-regimen-of-doravirine-islatravir-dor-isl-for-the-treatment-of-adults/
14. https://www.fiercebiotech.com/biotech/mercks-hiv-combo-treatment-meets-bar-viral-suppression-pair-phase-3-studies