Biologics

Novartis Brolucizumab BLA for Macular Degeneration

FDA has accepted a Novartis BLA for brolucizumab (RTH258) for treating wet age-related macular degeneration (AMD), also known as neovascular AMD. The company used a six-month priority review voucher to expedite FDA’s review.

The submission is based on Phase 3 data from the HAWK and HARRIER trials. The primary endpoint of these studies was non-inferiority to Regeneron’s aflibercept (Eylea) in mean change in best-corrected visual acuity from baseline to week 48. Additionally, the company says that at week 48 in the studies, key secondary endpoint assessments showed significantly fewer brolucizumab patients with disease activity (23.5% of brolucizumab 6 mg patients versus 33.5% of aflibercept patients in HAWK, and 21.9% versus 31.4%, respectively, in HARRIER.

Brolucizumab is a humanized single-chain antibody fragment and the most clinically advanced fragment to reach this stage of development, Novartis says. “Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics,” it says.

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