Health Canada Approves AbbVie’s Humira

Health Canada approved AbbVie’s Humira (adalimumab) for the treatment of adults with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics). This follows the drug’s approval by FDA, in 2002, and EMA, in 2003, for the treatment of moderate to severe rheumatoid arthritis.

According to a Jan. 6, 2016 press announcement from AbbVie, Humira is now the first Health Canada-approved therapy for the treatment of adults with HS. HS is a chronic, systemic, immune-mediated skin disease that affects between 1–3% of the global population, however, the diagnosis is often delayed or misdiagnosed; its true prevalence is unknown. The average Canadian HS patient will see five doctors during the course of 17 visits spanning eight years before being properly diagnosed.

HS has a greater impact on the quality of life of affected individuals compared to other dermatological conditions and is associated with intense pain and decreased mobility. The deep-seated lesions (nodules or abscesses) may be accompanied by unpleasant odor and purulent drainage. The lesions are present under the arms, groin, and perianal area, with the breasts being affected in female individuals. In time, the lesions can cluster and produce residual scarring.

Health Canada's approval for the treatment of HS adds to the record of clinical studies that Humira has established over its 11 years of use in immunology indications in Canada. This latest Health Canada approval is based on the results of two pivotal Phase III studies, PIONEER I and PIONEER II, and represents the ninth approved indication for Humira in Canada

Source: Canada Newswire