Healthcare Industry News:  calcineurin inhibitor 

Biopharmaceuticals Dermatology Regulatory

 News Release - January 23, 2009

Protopic(R) Ointment (tacrolimus monohydrate) Receives Positive Opinion for Twice-Weekly use (Maintenance Treatment) in the Treatment of Atopic Dermatitis by the European Medicines Agency

Innovative Treatment Approach Offers Major Step Forward in the Long-Term Management of this Chronic Disease

STAINES, England, January 23 -- (Healthcare Sales & Marketing Network) -- Astellas Pharma Europe Ltd announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion, recommending the approval of a twice-weekly application regimen of Protopic® ointment (tacrolimus monohydrate) for the prevention of flares and prolongation of flare-free periods. This regimen is indicated for appropriate adults and children 2 years of age and above, with moderate to severe atopic dermatitis who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).[1] The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union, to evaluate this recommendation and issue final authorisation. The Commission usually makes a decision within two to three months of the CHMP issuing its recommendation.

Atopic dermatitis, also known as atopic eczema, is an itchy, inflammatory skin condition that affects 14-24%[2,3] of the population and has a major impact on a person's quality of life. The standard approach to managing this condition has been to treat flares as and when they occur with topical anti-inflammatory agents, such as topical corticosteroids or topical calcineurin inhibitors. However, a deeper understanding of the pathology of this disease has revealed that subclinical inflammation persists, even after the clinical signs of flare have resolved.[4] This twice-weekly treatment regimen with Protopic ointment would allow physicians to actively manage the subclinical inflammation between flares in appropriate patients with moderate or severe disease to prevent flare recurrence and prolong the time that patients are free from flares.

"One of the major problems for patients is the impact of recurring eczema flares." said Dr Sakari Reitamo, Hospital for Skin and Allergic Diseases, Helsinki University Central Hospital, Helsinki, Finland. "This innovative treatment regimen of twice-weekly tacrolimus ointment is a response to the new understanding of how this disease can be controlled. Suppressing inflammatory activity between flares offers a major breakthrough in the reduction of flares to improve the long-term control of atopic eczema."

The CHMP's decision was based on results from two phase III CONTROL studies conducted in 524 adults and children in 13 European countries, which found that once patients had responded to twice- daily treatment of their flares with Protopic ointment, continuing treatment with a twice-weekly regimen significantly reduced the number of flares compared to a flare treatment only regimen.[5,6] Approximately half of the patients in the twice-weekly Protopic ointment group did not experience any flare during the 12 month study period.[7]

Astellas is committed to continuing to develop its strong dermatology franchise by meeting the ongoing needs of both physicians and patients. "We look forward to the anticipated approval from the European Commission and providing an effective long-term solution for improved control of eczema," said John Bolodeoku, senior VP of medical affairs, Astellas Pharma Europe Ltd.

Notes for Editors

About Protopic

Protopic ointment (tacrolimus monohydrate) has been marketed globally for the treatment of moderate to severe atopic dermatitis in appropriate adults and children 2 years of age and above since launching in Japan in 1999.8 This new indication is for maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). Protopic has been marketed in over 60 countries worldwide, including Japan, the US, and countries in Europe, Asia and Latin America.

About Astellas

Astellas Pharma Europe Ltd, located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organisation is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe is responsible for 20 affiliate offices located across Europe, the Middle East and Africa, two R&D sites and three manufacturing plants with approximately 3,300 staff.


Accessed 23rd January 2009.

2 Cork MJ, et al. Dermatology Update, Quebec, Nov 6-8, 2003: 1-7

3 Darsow U, et al. J Euro Acad Dermatology and Venereology 2005; 19:

4 Leung DY, Bogguiniewicz M, Howell MD et al. New insights into atopic
dermatitis Journal of Clinical Investigation 2004; 113:665-7

5 Wollenburg A, et al. Allergy 2008; 63: 742-750

6 Tha├ži D, et al. British Journal of Dermatology 2008;159:1348-56

7 Astellas data on file.

Accessed 23rd January 2009.

Source: Astellas Pharma

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