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Astellas Submits Application for Approval of fidaxomicin for the Treatment of Infectious Enteritis Caused by Clostridium difficile in Japan

11:00 EDT 31 Jul 2017 | Astellas Pharma Inc.

Tokyo, July 31, 2017 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) today announced that it has submitted an application for marketing approval of fidaxomicin (generic name) for the treatment of infectious enteritis (including pseudomembranous colitis1) (susceptible strains: fidaxomicin susceptible Clostridium difficile2).

Fidaxomicin is an oral macrocyclic antimicrobial agent3 with a new mechanism of action and a selective antibacterial spectrum licensed from Merck & Co., Inc. (“Merck”). It is already being marketed in the United States as a Clostridium difficile (“CD”) associated diarrhea and Europe as a CD infection treatment. Astellas has developed the product in Japan based on an exclusive development and marketing agreement with Merck. In addition, our subsidiary Astellas Pharma Europe Ltd. has acquired exclusive license for the development and commercialization in Europe, and additional countries in the Middle East, Africa and the Commonwealth of Independent States (CIS)4.

CD, a bacterium that infects large intestine and produces toxins, causes nosocomial infections and antibacterial agent-associated colitis worldwide. Infection and proliferation result in colitis and severe diarrhea and in the most serious cases death. As difficulty in treatment has been reported with the treatments of infectious enteritis  caused by CD which has already been approved in Japan, mainly due to recurrence, new treatment options have been needed. Besides its potent antibacterial activity against CD, due to its narrow antibacterial spectrum, it minimally disrupts the balance of intestinal flora, and it inhibits spore formation5.

Astellas expects to contribute to the advancement of the treatments of infectious enteritis caused by CD in Japan by providing fidaxomicin as a new therapeutic option.

Submission of the application for marketing approval has no impact on the financial results for the fiscal year 2017 ending March 31, 2018.

Original Article: Astellas Submits Application for Approval of fidaxomicin for the Treatment of Infectious Enteritis Caused by Clostridium difficile in Japan

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