Drugs

Merck Reports Positive Data on HIV Trials

Merck is announcing “positive results” from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir (DOR/ISL (100mg/0.25mg) in certain adults with HIV-1 infection that is virologically suppressed. It says an NDA will be submitted to FDA by mid-year.

The trials evaluated patients whose infection is virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (trial MK-8591A-052 ) or antiretroviral therapy (trial MK-8591A-051). “In both trials, DOR/ISL met the primary efficacy success criterion for non-inferiority to comparator antiretroviral therapies and primary safety objectives at Week 48,” Merck says.

The clinical trial program suffered a setback in 2021 when FDA placed clinical hold on the IND and other related INDs due to observations of decreases in total lymphocyte and CD4+ T-cell counts in some participants receiving islatravir in clinical studies, Merck said at the time (see story). The hold was lifted in 9/2022, at which time Merck announced it was also discontinuing the development of once-monthly oral islatravir for HIV-1 pre-exposure prophylaxis.

Merck says islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor that is designed to block HIV-1 replication by multiple mechanisms. Doravirine is currently approved and marketed as Pifeltro for combination use with other antiretroviral agents for treating HIV-1 infection. It is also approved under the brand name Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) as a complete regimen for treating HIV-1 infection.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome