Announcement of Approval of Additional Indication (Actinic Keratosis) for Beselna Cream 5%, a Therapeutic Agent for Condyloma Acuminatum
25 November 2011
(Tokyo, November 25, 2011) - Mochida Pharmaceutical Co., Ltd (Head Office: Shinjuku-ku, Tokyo,
Japan; President: Naoyuki Mochida) announces that Beselna Cream 5% (imiquimod) received
approval in Japan for the additional indication of actinic keratosis as of November 25.
Imiquimod is licensed by iNova Pharmaceuticals (Australia) Pty Limited, and is sold in Japan by
Mochida Pharmaceutical since December 2007 as a therapeutic agent for condyloma acuminatum. The
product has also been approved and widely used as a therapeutic agent for actinic keratosis in 48 other
countries and regions, and Mochida Pharmaceutical has carried out clinical testing for this additional
indication in Japan.
Actinic keratosis occurs when the skin is exposed to ultraviolet rays over a long period of time, and is
a condition that can progress to skin cancer if not treated. It occurs most frequently on the faces of
elderly people. Cryogenic surgery and surgical removal of the affected area are the mainstream
treatments for actinic keratosis in Japan, yet treatment with external medicine is common in other
countries. External treatment with imiquimod, without the need for anesthesia or surgery, has a high
response rate and is regarded as a useful choice for treatment.
Mochida Pharmaceutical expects that imiquimod will contribute considerably to improving quality of
life for patients as a new treatment option for actinic keratosis in Japan.