Sanofi (SNY.US) Antiallergic Drug "Fexofenadine" Applies for New Indications for Approval in China

On February 25th, the latest announcement on the official website of the China National Medical Products Administration Drug Evaluation Center (CDE) revealed that the new indication application for the oral suspension of levocetirizine hydrochloride filed by Sanofi (SNY.US) has been accepted for marketing approval. Previously, levocetirizine tablets had been approved in China for the treatment of allergic rhinitis and chronic idiopathic urticaria. The current application is for the oral suspension form, and this is the second marketing application for oral suspension form in China. According to a previous press release by Sanofi, the US FDA had approved levocetirizine hydrochloride oral suspension for the treatment of seasonal allergy-related symptoms in children aged 2-11, as well as chronic idiopathic urticaria in children aged 6 months to 11 years. It is speculated that the indications for the oral suspension form in China may also be seasonal allergies and chronic idiopathic urticaria in children. Compared to the tablet form, the oral suspension form may offer a more convenient treatment option for pediatric patients due to its good taste and ease of swallowing. According to publicly available information from Sanofi, levocetirizine is a second-generation antihistamine that has both antihistamine and anti-inflammatory effects. It is fast-acting, long-lasting for 24 hours, does not cause drowsiness, and has a low occupancy rate of brain receptors. Its high affinity for the H1 receptor indicates good cardiac safety. In terms of its mechanism of action, histamine H1 receptors are mainly found in endothelial cells of blood vessels, smooth muscle of the airways, and various other cells, which are closely related to allergic reactions. Antihistamines that target the histamine H1 receptor can down-regulate the receptors activated by histamine to their inactive state, reduce allergic inflammation, decrease the expression of pro-inflammatory cytokines and cell adhesion molecules, and weaken the chemotaxis of eosinophils, thereby exerting biological effects.