September 27, 2017

Notice regarding acquisition of manufacturing and sales approval for Rupafin® tablets

Teikoku Seiyaku Co., Ltd. (Head Office: Higashikagawa City, Kagawa; President and CEO: Misako Fujioka) and Mitsubishi Tanabe Pharma Corporation (Head Office: Osaka City; President and Representative Director: Masayuki Mitsuka) have announced that on September 27, 2017, Teikoku Seiyaku acquired manufacturing and sales approval for anti-allergy agent Rupafin® tablets (generic name: rupatadine fumarate). Rupafin® has indications of allergic rhinitis, urticaria, and pruritus accompanying skin disease (eczema, dermatitis, prurigo, cutaneous pruritus).

This oral allergy treatment agent has a new mechanism of action. In addition to antihistamine action, Rupafin® tablets also have anti-PAF (platelet activating factor) action. Histamine is widely known as a chemical mediator that brings about allergic reactions. PAF induces vasodilation, vascular permeability enhancement, vascular nerve stimulation, and white blood cell activation. As a result, it brings about such symptoms as sneezing, runny nose, and nasal congestion, and it is closely involved in the pathology of allergic disorders. Rupafin® tablets control these two chemical mediators and show strong dual action (anti-PAF and antihistamine), thereby controlling the symptoms of allergic disorders.
This drug was discovered by J. Uriach Y COMPANIA, S.A., of Spain, and had been approved in more than 80 countries around the world as of September 2017. Overseas, it has indications of allergic rhinitis and urticaria and is administered orally at a dosage of 10mg once a day. In Japan, in May 2014 Teikoku Seiyaku concluded a development and sales licensing agreement with J. Uriach Y COMPANIA, and Teikoku Seiyaku has advanced development on its own.

In October 2016, Teikoku Seiyaku and Mitsubishi Tanabe Pharma reached a basic agreement for sales of Rupafin® tablets. Teikoku Seiyaku will supply the product to Mitsubishi Tanabe Pharma, which will distribute and market it. In addition, the two companies will jointly implement information provision activities for medical institutions.