Astella Pharma Europe, a subsidiary of Astellas Pharma, has announced plans to launch its Protopic ointment in Europe.
The company is currently waiting for the approval of Protopic ointment (tacrolimus monohydrate), a topical calcineurin inhibitor for treatment of eczema.
Protopic ointment is licensed to treat severe eczema (atopic dermatitis), and approved for twice-weekly application by the patients.
The approval of the Protopic ointment's was based on the data demonstrated by two phase-III studies (CONTROL) conducted in 524 adults and children in 13 European countries.
The result demonstrated that once patients had responded to twice-daily treatment of their flares with Protopic ointment, continuing treatment to previously affected areas with a twice-weekly regimen significantly reduced the number of flares compared to a flare treatment-only regimen.