Merck Opens Enrollment in New Phase 3 Clinical Trials with Investigational Once-Daily Islatravir in Combination with Doravirine for Treatment of HIV-1 Infection
FDA Confirms Paragraph IV Patent Litigation for Delstrigo (Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate)
Sept 20 (Reuters) - Merck & Co Inc (MRK.N) said on Tuesday it would start fresh late-stage studies of its HIV treatment, islatravir, months after the U.S. Food and Drug Administration put the trials on hold, citing safety concerns.
Merck tested its approved treatment Pifeltro in combination with the investigational drug islatravir in adults with HIV-1 infection. Pifeltro, also known as doravirine, snagged FDA approvals as a single treatment and as a combo known as Delstrigo with other HIV drugs from GlaxoSmithKline's ViiV Healthcare and Gilead Sciences in August 2018.
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new analyses from the Phase 2b trial (NCT03272347) evaluating the safety and efficacy of islatravir, the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), in combination with doravirine (PIFELTRO™), in adults with HIV-1 infection who had not previously received antiretroviral treatment. The first sub-analysis further characterized the tolerability and safety profile of islatravir in combination with doravirine (100 mg) through Week 48 across the three dose levels studied (0.25, 0.75, 2.25 mg). The second sub-analysis demonstrated that participants who initiated treatment with islatravir and doravirine in combination with 3TC and switched to islatravir and doravirine maintained antiviral activity at Week 48 as measured by HIV-1 RNA <50 copies/mL similar to DELSTRIGO, with low rates of protocol defined virologic failure (PDVF). These latest findings will be made available this week in two oral presentations during the 23rd International AIDS Conference (AIDS 2020: Virtual). The primary endpoints and full study design of the Phase 2b Week 48 trial results were originally presented at IAS 2019.
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today upcoming presentations of new analyses from its HIV clinical development program during the 23rd International AIDS Conference (AIDS 2020: Virtual) taking place virtually from July 6-10, 2020. The presentations include Week 48 safety and virologic failure data from the Phase 2b trial evaluating islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), with doravirine, the company’s non-nucleoside reverse transcriptase inhibitor (NNRTI), in adults with HIV-1 infection who had not previously received antiretroviral treatment. The data presentations also include a post-hoc analysis of weight change from the Phase 3 DRIVE-SHIFT trial evaluating the effect of switching to DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) as well as an examination from the OPERA cohort of weight changes in people living with HIV.
The FDA on Thursday officially ended a fledgling pilot program that was part of an effort to provide more transparency on the drug approval process. The agency said it’s working on a new approach to disclosing study reports.
Merck has announced that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO™ (in combination with other antiretroviral agents) and DELSTRIGO™ (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to PIFELTRO or the individual components of DELSTRIGO.
The U.S. Food and Drug Administration (FDA) approved Merck & Co.’s supplemental New Drug Applications (sNDAs) for Pifeltro (doravirine) in combination with other antiretroviral medicines and Delstrigo (doravine/lamivudine/tenofovir disoproxil fumarate) for HIV-1 patients who are switching from a stable antiretroviral regimen and whose virus is suppressed, meaning HIV-1 RNA is less than 50 copies per mL.
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