Drugs

Kodiak Plans Another Study on Eye Drug

Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three indications — macular edema following retinal vein occlusion, wet age-related macular degeneration and non-proliferative diabetic retinopathy (NPDR). Kodiak says the regulatory pathway was recently discussed with FDA reviewers, including data from the company’s Phase 3 GLOW superiority study evaluating tarcocimab tedromer 5 mg in moderately severe to severe NPDR, which met its one-year primary endpoint.

“We think that the consistency of the data across all endpoints, where tarcocimab significantly improved the diabetic eye disease status and, importantly, significantly prevented sight-threatening complications, is remarkable,” the company says. “The GLOW data reinforce the durability potential of tarcocimab and the antibody biopolymer conjugate platform (ABC Platform) in the management of retinal vascular diseases.”

Last year, Kodiak paused the development of tarcocimab after its GLEAM and GLIMMER studies in diabetic macular edema did not meet their primary endpoint. The pause allowed data from its pivotal BEACON study in patients with macular edema due to retinal vein occlusion and the GLOW study to mature.

In the GLOW study, tarcocimab met its primary endpoint of the proportion of patients with at least a two-step improvement on the Diabetic Retinopathy Severity Scale score, the company says. “Tarcocimab achieved a 29-fold increased response rate ratio, with 41.1% of evaluable patients on tarcocimab demonstrating at least two-step improvement versus 1.4% of evaluable patients in the sham group (p less than 0.0001),” it says. “Visual acuity and retinal anatomy were improved and stable with tarcocimab on its extended-dosing intervals.”

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