Today (February 19), the drug approval document pending information issued by the National Food and Drug Administration (NMPA) shows that Sanofi's anti-allergic drug fexofenadine hydrochloride has been listed in three applications.
Officially approved in China.
According to public information, fexofenadine hydrochloride tablets are an H1 receptor antagonist.
The approved indications for this drug may be allergic rhinitis and chronic idiopathic urticaria.
Screenshot source: NMPA official website
There are at least four subtypes of histamine receptors (H1 receptor, H2 receptor, H3 receptor and H4 receptor) in target cells of the human cardiovascular system, skin, smooth muscle and stomach.
Among them, histamine H1 receptors are mainly distributed in a variety of cells such as vascular endothelium and airway smooth muscle, and are closely related to allergic reactions.
When the histamine H1 receptor is activated, capillaries dilate and increase in permeability, smooth muscle contraction of the respiratory tract and digestive tract, and increased secretion of glands, resulting in a series of allergies such as itching, erythema, runny nose, sneezing, asthma, eye itching, etc.
Antihistamines targeting histamine H1 receptors can down-regulate the receptors activated by histamine to an inactive state, down-regulate allergic inflammation, reduce the expression of pro-inflammatory cytokines and cell adhesion molecules, and weaken eosinophils Chemotaxis of cells, etc.
, and then exert biological effects.
At present, antihistamines are mainly divided into two types, first-generation and second-generation.
Second-generation antihistamines have the characteristics of better receptor specificity and selectivity, and low incidence of central inhibition.
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 has a good antihistamine effect.
In the United States, the drug has been approved by the FDA: it can not only be used to relieve seasonal and perennial allergic rhinitis-related symptoms in adults and children over 12 years old, these symptoms include sneezing, runny nose, watery eyes, itching, and red eyes And nose/palate/throat itching; it can also be used to relieve chronic idiopathic urticaria-related symptoms in adults and children over 12 years old.
According to information on Sanofi's official website, fexofenadine hydrochloride can inhibit skin flares and flare reactions induced by histamine.
After single and two oral administrations per day, the antihistamine effect occurs within 1 hour, reaches a maximum in 2 to 3 hours, and lasts for at least 12 hours.
After 28 days of administration, no tolerance was found.
In a number of randomized, double-blind, placebo-controlled clinical trials, 60 mg of fexofenadine hydrochloride and 120 mg of fexofenadine hydrochloride twice a day can effectively reduce the symptoms of seasonal allergic rhinitis (spring Trees and grasses or pollen in autumn) and perennial allergic rhinitis (animal dander, dust mites and mold).
These symptoms include sneezing, runny nose, itchy nose/palates/throat, and itchy eyes, watery eyes, Redness.
In addition, fexofenadine hydrochloride can also effectively relieve the symptoms and signs of chronic idiopathic urticaria, including itching and rubella.
And in the analysis of different age, gender, race or weight subgroups, there is no significant difference in the treatment effect.
Congratulations to Sanofi's anti-allergic drug fexofenadine hydrochloride tablets for approval in China, giving allergic patients new treatment options!