MUNICH, Germany, Oct. 23 /PRNewswire/ -- Fujisawa GmbH announced today
that the Committee for Proprietary Medicinal Products (CPMP), the scientific
advisory body of the European Medicines Evaluation Agency (EMEA), has given
its positive opinion on the marketing authorisation for Protopic(R)
(tacrolimus ointment), developed for the treatment of atopic dermatitis.
Protopic(R) represents the first in a new class of agents, the so-called
topical immunomodulators (TIMs), acting selectively through a non-steroidal
pathway. It targets the immunological imbalance of the skin associated with
atopic dermatitis, thereby restoring the skin's normal function and preventing
the release of inflammatory mediators and cytokines, leading to reduced skin
inflammation, redness and itching.
The benefits with Protopic(R) pertain to its selective mechanism of
action, without causing the side-effects known from conventional therapy with
topical corticosteroids like thinning of the skin. Therefore, in addition to
being effective on the body and limbs, it is also suitable for treating
sensitive or hard to treat skin areas like face and neck.
The CPMP based its evaluation on data from clinical studies involving more
than 10,000 patients and found Protopic(R) to be safe and effective for the
treatment of moderate to severe atopic dermatitis. The 0.1% and the 0.03%
concentrations of tacrolimus ointment were approved for adults who are not
adequately responsive to or intolerant of conventional therapies and the 0.03%
strength for the treatment of children two years of age and above who failed
to respond adequately to conventional therapies.
Having now received the positive CPMP opinion, the marketing authorisation
for Protopic(R) in all European Union member countries is expected in the
first quarter of 2002.
Protopic(R) has been commercially available in Japan since November 1999,
in the US since early 2001 and in Canada since September this year. An
application for the use of tacrolimus ointment in atopic dermatitis was
submitted to the licensing authorities of Switzerland, Taiwan and China. In
Korea, marketing approval was obtained in October 2001.
Fujisawa GmbH is a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based
in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a
leading pharmaceutical manufacturer and is actively developing its
international operations in North America, Europe and Asia. With the
development of Protopic(R) and the commitment to dermatology Fujisawa entered
a new core business segment, next to transplantation and antibiotics.
Additional information on Fujisawa GmbH can be found on the Company's Web site
at http://www.fujisawaeurope.com
SOURCE Fujisawa GmbH
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Related links:
http://www.fujisawaeurope.com
CONTACT:
Marite Cruz of Fujisawa GmbH, +49 89
45442249, or fax, +49 89 434129, or marite.cruz@fujisawa.de
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