Drugs

FDA OKs Regeneron’s High-Dose Eylea

FDA has approved Regeneron Pharmaceuticals’ Eylea HD (aflibercept 8 mg) for treating macular edema following retinal vein occlusion (RVO), giving the drug a new indication that allows dosing as infrequently as every eight weeks after an initial monthly loading period. The agency also approved a monthly dosing option across all approved uses of Eylea HD, offering physicians more flexibility in tailoring treatment for retinal diseases.

The company says the decision makes Eylea HD the first RVO therapy approved for extended eight-week dosing, which could reduce injection frequency compared with existing anti-vascular endothelial growth factor treatments. Eylea HD is already approved in the U.S. for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

The RVO approval is supported by data from the the Phase 3 QUASAR trial, which compared Eylea HD with the original 2 mg Eylea formulation, according to the company. At 36 weeks, patients receiving Eylea HD every 8 weeks achieved non-inferior visual acuity gains versus patients treated with 2 mg Eylea every 4 weeks.

Regeneron notes that adverse events occurring in 3% or more of patients included elevated intraocular pressure, blurred vision, cataract, conjunctival hemorrhage, eye pain or irritation, and vitreous detachment.

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

Read more

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