WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced several significant developments this week, spanning advancements in allergy treatment, diabetes management, and Parkinson’s disease therapy, as well as a critical food safety recall linked to a Listeria outbreak.
On Thursday, February 27, the FDA approved Odactra for use in children aged 5 through 11 to treat house dust mite-induced allergic rhinitis, with or without conjunctivitis. Previously approved for individuals aged 12 to 65, Odactra is administered sublingually as an allergen extract immunotherapy. Its prescribing information includes a boxed warning about the risk of severe, potentially life-threatening allergic reactions, emphasizing the need for epinephrine availability during treatment.
The FDA also updated its advisory on the ongoing Listeria monocytogenes outbreak linked to frozen supplemental shakes. Lyons Magnus LLC has recalled 4 oz. Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes. As of February 24, the outbreak has affected 21 states, resulting in 37 hospitalizations and 12 reported deaths among the 38 confirmed cases.
On Monday, February 24, the FDA cleared Tandem Diabetes Care, Inc.’s Control-IQ+ technology, an interoperable automated glycemic controller (iAGC). Building on prior systems, this latest version is approved for type 1 diabetes in individuals as young as two and for type 2 diabetes in adults 18 and older. It offers advanced features like automatic insulin adjustments based on glucose monitoring, demonstrating the FDA’s commitment to innovation in diabetes management.
Lastly, on February 21, the FDA approved a software update for Medtronic Inc.’s Deep Brain Stimulation Therapy System. The update introduces adaptive deep brain stimulation (aDBS), allowing stimulation levels to adjust based on detected brain signals. The system aims to offer personalized treatment for Parkinson’s patients whose symptoms remain uncontrolled with medication after at least four years.
These developments underscore the FDA’s broad focus on improving public health through enhanced therapies, safety measures, and advanced technologies.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.