Drugs

FDA Approves Novartis’ Rhapsido for Urticaria

FDA has approved a Novartis NDA for Rhapsido (remibrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor for treating adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine therapy. Taken as a twice-daily pill, Rhapsido is designed to block BTK, a protein that activates immune cells responsible for the release of histamine and other inflammatory mediators linked to CSU symptoms, the company says. Unlike injectable options, the oral therapy requires no lab monitoring, it adds.

CSU (also referred to as chronic hives) affects about 1.7 million people in the U.S. Symptoms can be unpredictable, recurring for weeks or months at a time, and can significantly disrupt sleep, work, and quality of life, Novartis says. While antihistamines are the standard first-line treatment, more than half of patients remain symptomatic even at higher doses.

Approval was based on clinical trial data from Novartis’ Phase 3 REMIX-1 and REMIX-2 studies. Patients receiving Rhapsido showed significant improvements in itch, hives, and overall urticaria activity scores compared with placebo, it says. Well-controlled disease was observed as early as two weeks, with one-third of patients experiencing complete relief of itch and hives at 12 weeks. The most common side effects included mild respiratory symptoms, bleeding, headache, nausea, and abdominal pain.

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