LITFULO™ Receives Health Canada Approval, Becoming the First Approved Treatment for Severe Alopecia Areata in Canada.

A dual JAK3/TEC inhibitor, LITFULO™ (ritlecitinib) is approved for adults and adolescents over 12 years of age for treatment of severe alopecia areata.

KIRKLAND, QC, Dec. 4, 2023 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance (NOC) for LITFULO™ (ritlecitinib). A once-daily oral treatment, LITFULO is the first and only treatment approved by Health Canada for individuals 12 years of age and older with severe alopecia areata.ⁱ Approximately two per cent of the global population are affected by alopecia areata which is an autoimmune disease where the immune system attacks the body's hair follicles causing patchy to complete hair loss on the scalp, face and/or body. ^ii,iii,iv

"For patients with substantial hair loss, alopecia areata can be difficult to manage physically and emotionally, especially for younger people," said Dr. Melinda Gooderham, dermatologist at the SKiN Centre for Dermatology in Peterborough, Ontario. "As a physician, it has been frustrating to have so little to offer patients. I'm pleased to have a new option available."

An estimated 775,000 Canadians are affected by alopecia areata at some point in their lifetime, with most people starting to show signs in their teens through to their 30s. However, patients can start to develop symptoms at any age with nearly 20 per cent of people being diagnosed before the age of 18.^v,vi,vii

"Alopecia areata has a devastating impact on a person's mental health and quality of life," said Carolynne Harrison, President of the Canadian Alopecia Areata Foundation (CANAAF). "Until now, there have been no approved medical treatment options to help patients and their families living with this condition. The alopecia community across Canada is looking forward to access to a new treatment option for both adolescents and adults with the severe form of alopecia areata."

About Alopecia Areata

Alopecia areata is a T cell-mediated autoimmune disease affecting the hair follicles. Inflammation in the hair follicles causes hair loss and the loss of the ability to regrow hair until the response is suppressed.^viii This hair loss often occurs on the scalp, but it can also affect eyebrows, eyelashes, facial hair, and other areas of the body^.ix,x Alopecia areata can affect people of any age, gender, race, or ethnicity and can cause considerable burden beyond hair loss.^{xi,xii,xiii,xiv}

"The approval of LITFULO marks an important milestone for Canadians, including those as young as 12, living with severe hair loss from alopecia areata," said Frédéric Lavoie, Inflammation and Immunology Lead for Pfizer Canada. "This approval represents the first treatment option approved by Health Canada for severe alopecia areata. As a leader in inflammation and immunology, we at Pfizer Canada are immensely proud to be bringing this new option for Canadians living with this challenging autoimmune disease."

Pfizer Canada is currently assessing the timeline for the availability of LITFULO in Canada and is committed to bringing supply of this medicine to Canadians as quickly as possible.

About LITFULO™

LITFULO is used to treat severe alopecia areata in people 12 years of age and older.^xv LITFULO is an inhibitor of JAK3 and the TEC family kinases.^xvi Inhibition of JAK3 and TEC kinase family members by LITFULO may block signaling of cytokines and cytolytic activity of T cells, which is implicated in the pathogenesis of alopecia areata.^xvii

About Pfizer Canada

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care 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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^i	LITFULO Product Monograph. Available at www.pfizer.ca. November 29, 2023.
^ii	Canadian Alopecia Areata Foundation. What is Alopecia Areata? Accessed November 2023 at https://www.canaaf.org/about-alopecia-areata/.
^iii	Canadian Dermatology Association. Alopecia. Accessed November 2023 at https://dermatology.ca/public-patients/hair/alopecia/
^iv	Islam N, Leung PSC, Huntley AC, et al. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015:14(2):81-89.
^v	National Institute of Arthritis and Musculoskeletal and Skin Diseases. Alopecia Areata. Accessed November 2023 at https://www.niams.nih.gov/health-topics/alopecia-areata
^vi	Caldwell CC, Saikaly SK, Dellavalle RP, et al. Prevalence of pediatric alopecia areata among 572,617 dermatology patients. J Am Acad of Dermatol. 2017;77(5):980-981.
^vii	Gilding AJ, Ho N, Pope E, Sibbald C. The Burden of Disease in Alopecia Areata: Canadian Online Survey of Patients and Caregivers. JMIR Dermatol. 2022 Oct 6;5(4):e39167
^viii	Canadian Alopecia Areata Foundation. What is Alopecia Areata? Accessed November 2023 at https://www.canaaf.org/about-alopecia-areata/.
^ix	Canadian Dermatology Association. Alopecia. Accessed November 13, 2023 at https://dermatology.ca/public-patients/hair/alopecia/
^x	Islam N, Leung PSC, Huntley AC, et al. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015:14(2):81-89.
^xi	Canadian Dermatology Association. Alopecia. Accessed November 13, 2023 at https://dermatology.ca/public-patients/hair/alopecia/
^xii	Islam N, Leung PSC, Huntley AC, et al. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015:14(2):81-89.
^xiii	Food and Drug Administration. The voice of the patient: a series of reports from the U.S. Food and Drug Administration's (FDA's) patient-focused drug development initiative. Silver Spring, MD:FDA;2018. Available from: https://www.fda.gov/files/about%20fda/published/Alopecia-Areata--The-Voice-of-the-Patient.pdf. Accessed November 11, 2023.
^xiv	Stefanaki C, Kontochristopoulos G, Hatzidimitrakib E, et al. A Retrospective Study on Alopecia Areata in Children: Clinical Characteristics and Treatment Choices. Skin Appen Dis. 2021.
^xv	LITFULO Product Monograph. Available at www.pfizer.ca. November 29, 2023.
^xvi	Ibid.
^xvii	Ibid.

SOURCE Pfizer Canada

Corporate Affairs Canada, 1-866-9Pfizer (1 866 973-4937), [email protected]