Drugs

Merck NDA Accepted for HIV Combination Therapy

FDA has accepted for review a Merck NDA for its investigational once-daily HIV treatment combining doravirine and islatravir (DOR/ISL). The two-drug regimen is intended for adults with HIV-1 infection who are already virologically suppressed on existing antiretroviral therapy. The agency has set a user fee review action target date of 4/28/2026.

The submission is based on data from two Phase 3 trials — MK-8591A-051 and MK-8591A-052 — that demonstrated DOR/ISL’s efficacy and safety in maintaining viral suppression, the company says. In the open-label MK-8591A-051 trial, 551 adults who were virologically suppressed on two- or three-drug antiretroviral regimens were randomized to either switch to DOR/ISL or continue their existing therapy. The DOR/ISL regimen demonstrated non-inferiority in maintaining viral suppression at 48 weeks, with a comparable safety profile, it says.

Merck says its double-blind MK-8591A-052 trial enrolled 513 adults on the triple-combination regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Participants were randomized to either switch to DOR/ISL or continue BIC/FTC/TAF. Again, DOR/ISL was found to be non-inferior at maintaining suppression of HIV-1 RNA levels, with a comparable safety profile, according to the company.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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