Sanofi Submits NDA for Fexofenadine Hydrochloride Oral Suspension in China

Feb 08, 2025 10:29 CST Updated 10:29

Sanofi

Pharmaceutical R&D Developer

▎Edited by the WuXi AppTec content team

Today (February 8),The latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA),Sanofi (Sanofi) submittedFexofenadine Hydrochloride Oral SuspensionThe listing application has been accepted. Public information shows,Fexofenadine is a second-generation new type of antihistamine.Previously, fexofenadine tablets have been approved in China for the treatment of allergic rhinitis and chronic idiopathic urticaria. This submission for marketing approval is forOral Suspension Formulation。

Screenshot source: CDE official website

At least four subtypes of histamine receptors (H1 receptor, H2 receptor, H3 receptor, and H4 receptor) are present in the target cells of the human cardiovascular system, skin, smooth muscle, and stomach. Among them, the histamine H1 receptor is mainly distributed in various cells such as vascular endothelium and airway smooth muscle, and is closely related to allergic reactions.Antihistamines targeting histamine H1 receptors can downregulate the activated receptors to an inactive state, reduce allergic inflammation, decrease the expression of pro-inflammatory cytokines and cell adhesion molecules, and attenuate the chemotaxis of eosinophils, thereby exerting biological effects.

According to a previous press release from Sanofi,Fexofenadine is a second-generation new type of antihistamine, characterized by rapid onset, 24-hour long duration, no drowsiness, and low brain receptor occupancy. Its high affinity for the H1 receptor indicates better cardiac safety.

In 2021, Sanofi developedFexofenadine HydrochlorideTablet FormulationApproved for marketing by NMPA,For the treatment of allergic rhinitis and chronic idiopathic urticariaCurrently, Sanofi has developed multiple formulations for this product, including capsules, tablets, and combination preparations.In 2006, the pediatric oral suspension of this product was approved for marketing in the United States.Public information shows,Oral suspension may help compared to tablet formulations.Provide more convenient treatment options for people with dysphagia.

The submission of this fexofenadine oral suspension for marketing approval in China signifies that the product is expected to benefit a broader patient population in the future.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Feb 8, 2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]Heavyweight | Fexofenadine Original Drug Allegra® Ai Li Min® Launched in China. RetrievedDec 30, 2022, from https://mp.weixin.qq.com/s/jdXKx8kpesLkDG8HqudONg

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