Sanofi's Antihistamine Fexofenadine Hydrochloride Tablets Receive NMPA Approval in China for Allergic Rhinitis and Chronic Idiopathic Urticaria

Today (February 19), the National Medical Products Administration (NMPA) of China released information indicating that three marketing applications for Sanofi’s antihistamine drug, fexofenadine hydrochloride tablets, have been officially approved in China. According to public information, fexofenadine hydrochloride tablets are an H1 receptor antagonist, and the indications for this approval may include allergic rhinitis and chronic idiopathic urticaria.

Screenshot source: NMPA official website

At least four subtypes of histamine receptors (H1, H2, H3, and H4 receptors) are present in the target cells of the human cardiovascular system, skin, smooth muscle, and stomach. Among these, histamine H1 receptors are primarily distributed in various cells, including vascular endothelium and airway smooth muscle, and are closely associated with allergic reactions. Upon activation of histamine H1 receptors, capillary dilation and increased permeability occur, along with contraction of respiratory and gastrointestinal smooth muscles and increased glandular secretion, leading to a series of allergic symptoms such as pruritus, erythema, rhinorrhea, sneezing, wheezing, and ocular itching.

Antihistamines targeting the histamine H1 receptor can downregulate histamine-activated receptors to an inactive state, suppress allergic inflammation, reduce the expression of pro-inflammatory cytokines and cell adhesion molecules, and attenuate the chemotaxis of eosinophils and other cells, thereby exerting their biological effects. Currently, antihistamines are mainly classified into first-generation and second-generation agents. Second-generation antihistamines are characterized by greater receptor specificity and selectivity, as well as a lower incidence of central nervous system depression.

Fexofenadine Hydrochloride (Allegra) is a second-generation H1 receptor antagonist developed by Sanofi. It is an active metabolite of terfenadine in the human body and exhibits potent antihistaminic effects. In the United States, this medication has been approved by the FDA for marketing. It is indicated not only for the relief of symptoms associated with seasonal and perennial allergic rhinitis in adults and children aged 12 years and older—including sneezing, rhinorrhea, watery eyes, pruritus, red eyes, and itching of the nose, palate, or throat—but also for the relief of symptoms associated with chronic idiopathic urticaria in adults and children aged 12 years and older.

According to information on the Sanofi website, fexofenadine hydrochloride can inhibit histamine-induced skin wheal and flare responses. After once-daily and twice-daily oral administration, the antihistaminic effect occurs within 1 hour, reaches its maximum at 2 to 3 hours, and lasts for at least 12 hours. No tolerance was observed after 28 days of administration.

In multiple randomized, double-blind, placebo-controlled clinical trials, fexofenadine hydrochloride at doses of 60 mg twice daily and 120 mg twice daily effectively alleviated symptoms of seasonal allergic rhinitis (due to tree and grass pollen in spring or ragweed pollen in autumn) and perennial allergic rhinitis (due to animal dander, dust mites, and mold). These symptoms included sneezing, rhinorrhea, itching of the nose/palate/throat, as well as ocular itching, lacrimation, and redness. Furthermore, fexofenadine hydrochloride effectively relieved the symptoms and signs of chronic idiopathic urticaria, including pruritus and the number of wheals. Subgroup analyses across different ages, sexes, races, and body weights showed no significant differences in treatment efficacy.

Congratulations on the approval of Sanofi’s antiallergic drug, fexofenadine hydrochloride tablets, in China, providing patients with allergies a new treatment option!

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