Astellas' Protopic receives Health Canada approval for prevention of eczema flares

Astellas Pharma Canada, Inc. has announced that it has received approval from Health Canada for a new indication for its topical eczema therapy, Protopic^® (tacrolimus ointment 0.03% and 0.1%). The new indication means that tacrolimus ointment can be prescribed for maintenance therapy to prevent flares and prolong flare free intervals in patients with moderate to severe atopic dermatitis (commonly called eczema). These are individuals who experience a high frequency of flares (≥ 5 times per year). Tacrolimus ointment, a steroid-free topical agent, is a topical calcineurin inhibitor (TCI) also indicated for the intermittent-treatment of moderate to severe atopic dermatitis in non-immunocompromised patients.

"We're excited to be able to offer eczema sufferers an effective option to help prevent the chronic recurrence of eczema flares," said Michael Tremblay, President of Astellas Pharma Canada, Inc. "Patients can now enjoy being symptom-free for longer periods, ultimately improving their overall quality of life, which is always our primary objective at Astellas."

"This new indication is an important adjunct to our treatment armamentarium because atopic dermatittis is in so many cases a lifelong episodic skin disorder, and an important goal of treatment is to prevent or delay recurrent skin exacerbations," said Dr. Harvey Lui, MD, FRCPC, Professor and Head, Department of Dermatology and Skin Science, Vancouver General Hospital, University of British Columbia. "While patients are typically accustomed to using this topical therapy when they are experiencing an eczema flare, our challenge will be to educate them and their health care providers on the new use of tacrolimus ointment on their clear skin for preventing the flare from coming back."