HEALTH CANADA APPROVES THE USE OF EUCRISA IN CHILDREN AS YOUNG AS 3 MONTHS FOR MILD-TO-MODERATE ATOPIC DERMATITIS

15/07/21

July 15, 2021 – Kirkland, Qc – Pfizer Canada ULC announced that Health Canada has approved the revision to the minimum approved age for the use of EUCRISA (crisaborole) from two years of age to three months for patients suffering from mild-to-moderate atopic dermatitis (AD).¹

Atopic dermatitis, often called eczema, is a chronic skin condition characterized by inflammation of the skin and skin barrier defect that is often accompanied by intense itching.^2,3 While some patients experience periods of remission, others never experience complete remission and it becomes a lifelong condition to manage.⁴ Ten to fifteen per cent of Canadian children under the age of five are affected by atopic dermatitis and 40% will live with the condition throughout adulthood.⁵

Parents of children living with AD can be particularly burdened by the lack of sleep and by the emotional weight of seeing their child suffer⁶. “Helping a child manage flare ups is not an easy task for parents caring for younger patients who suffer from atopic dermatitis,” shared Amanda Cresswell-Melville, Executive Director of Eczema Society of Canada. “When a child suffers from eczema, it impacts the whole family.”

The expanded indication of EUCRISA for use in children over the age of three months is based on data from a phase four, open-label safety study of crisaborole ointment 2% in children aged three months to less than 24 months with mild to moderate atopic dermatitis.

“The expanded indication of EUCRISA is a testament to Pfizer Canada’s commitment to support patients who suffer from this chronic skin condition⁴,” said Stella Ananthan, Inflammation & Immunology Lead, Pfizer Canada.

About EUCRISA (crisaborole) ointment, 2%
EUCRISA is indicated for the topical treatment of mild to moderate atopic dermatitis in adults and pediatric patients 3 months of age and older. [PM, p. 1a, 4a]

Relevant warnings and precautions

• Hypersensitivity reactions, including contact urticaria [PM, p. 5B]

• Use in pregnant and nursing women [PM, p. 6A]

• Use in geriatric patients [PM, p. 6B]

For more information

Consult the Product Monograph at http://pfizer.ca/pm/en/Eucrisa.pdf for information regarding adverse reactions, drug interactions, and dosing. The Product Monograph is also available by calling 1-800-463-6001.

About Pfizer Canada

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified healthcare portfolio includes some of the world’s best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.

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For further information:

Corporate Affairs Canada

1-866-9PFIZER (1-866-973-4937)

[email protected]

¹EUCRISA^TM Product Monograph. May 18, 2021.

²Bieber T. Atopic dermatitis. Dermatol. 2012;1(3):203-217.

³Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.

⁴Eczema Society of Canada (2017) Atopic Dermatitis:Patient Insights Report Available at: https://eczemahelp.ca/wp-content/uploads/2019/02/ESC_Insights-Report_Nov-2017-1.pdf

⁵Canadian Skin Patient Alliance, Atopic Dermatitis (Eczema) Overview: What is Atopic Dermatitis https://www.canadianskin.ca/atopic-dermatitis-eczema

⁶Drucker AM, Wang AR, Li WQ, Sevetson E, Block JK, Qureshi AA. The burden of atopic dermatitis: summary of a report for the National Eczema Association. J Invest Dermatol 2017;137(1):26-30.