Drugs

Genentech Vabysmo sBLA for Macular Edema

FDA has accepted for review a Genentech supplemental BLA for Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion. The submission is based on data from two Phase 3 studies (BALATON and COMINO) showing that the therapy provided early and sustained improvement in vision, which met the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept, according to the company. Vabysmo’s safety profile was consistent with previous trials, it adds.

“Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared to aflibercept patients as seen in a pre-specified exploratory endpoint,” Genentech says. “Blood vessel leakage in the macula may lead to more retinal fluid, which can cause swelling and blurry vision.”

Vabysmo is described as a vascular endothelial growth factor inhibitor and angiopoietin-2 inhibitor. It was originally approved 1/2022 for treating patients with neovascular age-related macular degeneration and diabetic macular edema.

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