Drugs

GSK Long-Acting Biologic Approved for Asthma

GSK has won FDA approval for Exdensur (depemokimab-ulaa), the first ultra-long-acting biologic for severe asthma in the U.S., with dosing just twice a year. The product was approved as an add-on maintenance treatment for adults and adolescents aged 12 and older with severe asthma driven by an eosinophilic phenotype, according to the company.

Approval was based on data from the Phase 3 SWIFT-1 and SWIFT-2 trials, which enrolled more than 760 patients with uncontrolled severe asthma despite standard of care. In the studies, depemokimab cut annualized asthma exacerbation rates by 58% and 48%, respectively, versus placebo over 52 weeks, GSK says. The company also pointed to fewer exacerbations requiring hospitalization or emergency department visits, with a pooled analysis showing a 72% reduction in those severe events compared with placebo.

The twice-yearly dosing could give depemokimab an edge as physicians weigh biologic options for patients who struggle with frequent injections, GSK says. Current asthma biologics typically require dosing every two to eight weeks, a factor that has been linked to underuse despite strong efficacy data. GSK estimates that only about 20% of eligible U.S. patients with severe asthma are currently treated with a biologic.

Severe asthma affects about two million people in the U.S., and about half continue to experience frequent exacerbations that drive hospitalizations and healthcare costs, according to company figures. GSK is betting that longer dosing intervals will improve adherence and expand uptake among both patients and prescribers.

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