Protopic(R) Ointment Receives Positive Opinion For Twice-weekly Use In The Treatment Of Atopic Dermatitis By The European Medicines Agency

Main Category: Dermatology
Also Included In: Eczema / Psoriasis
Article Date: 26 Jan 2009 - 1:00 PDT

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Astellas Pharma Europe Ltd announced 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).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% 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.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. Approximately half of the patients in the twice-weekly Protopic ointment group did not experience any flare during the 12 month study period.

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.

Astellas Pharma Europe Ltd