Biologics

UCB’s Rystiggo Approved for Myasthenia Gravis

FDA has approved a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive. The company describes the subcutaneous infusion as a IgG4 monoclonal antibody that binds to the neonatal Fc receptor, resulting in the reduction of circulating immunoglobulin G.

gMG is a rare disease that affects patients with severe muscular weakness that can result in life-threatening weakness in respiration, according to the company. It also causes double vision, drooping eyelids, and difficulty swallowing, chewing and talking.

Approval was based on clinical trial data that showed a statistically significant difference favoring rozanolixizumab compared to placebo in measures of breathing, talking, swallowing, and being able to rise from a chair. The most common adverse reactions were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea, the company 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