Drugs

GSK Highlights Depemokimab Asthma Data

GSK says data from its SWIFT-1 and SWIFT-2 Phase 3 clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation. The findings were presented at the 9/9 European Respiratory Society International Conference in Vienna and published simultaneously in the New England Journal of Medicine.

Both SWIFT-1 and SWIFT-2 trials demonstrated that depemokimab substantially lowered the annualized rate of clinically significant asthma exacerbations by 54% compared to placebo over 52 weeks, according to GSK. Specifically, patients treated with depemokimab experienced 0.51 exacerbations per year, while those receiving placebo had 1.11 exacerbations per year. Additionally, the data showed a 72% reduction in exacerbations requiring hospitalization or emergency care, it adds.

GSK says depemokimab is noteworthy for its ultra-long-acting dosing schedule, with only two injections required per year. This could address issues related to medication adherence and frequent healthcare visits, potentially transforming asthma management

Depemokimab is designed to target interleukin-5 (IL-5), a key cytokine involved in Type 2 inflammation, which is prevalent in over 80% of severe asthma cases, the company says. The trials also documented no new safety concerns, with similar rates of adverse events in the depemokimab and placebo groups. The most common adverse events were COVID-19 and nasopharyngitis, and there were no significant differences between treatment and placebo groups, it adds.

The drug is currently under investigation in additional Phase 3 trials for eosinophilic granulomatosis with polyangiitis, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.

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