Biologics

FDA Approves Celltrion’s Eylea Biosimilar

FDA has approved Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayer’s blockbuster Eylea (aflibercept) for treating several major retinal diseases, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

FDA’s decision was based on analytical, nonclinical, and clinical data showing no clinically meaningful differences between Eydenzelt and Eylea, according to Celltrion. In a 52-week Phase 3 trial involving 348 patients with diabetic macular edema, Eydenzelt met predefined equivalence criteria for improvements in best corrected visual acuity at Week 8, the study’s primary endpoint, it says. Safety, pharmacokinetics, and immunogenicity results were also comparable to Eylea.

Aflibercept is described as a VEGF inhibitor that blocks vascular endothelial growth factor-A and placental growth factor, slowing abnormal blood vessel growth and fluid leakage in the eye.

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