Abbott has submitted a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) and a type II variation to the European Medicines Agency (EMEA) seeking approval to market Humira (adalimumab) as a treatment for moderate to severe chronic plaque psoriasis. Psoriasis affects 125 million people worldwide and is the fifth autoimmune disease targeted for Humira therapy in both the US and Europe.
Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself and create raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than skin lesions; it is painful and can impact many aspects of a person's life from professional and social activities to personal relationships. People with psoriasis may also suffer from poor self-image and social isolation.
The global submissions are based on the results of two double-blind, placebo-controlled trials of Humira - Reveal and Champion. In both trials, reduction in disease activity was determined by the Psoriasis Area and Severity Index (PASI) score, which measures the extent and severity of psoriasis.
"With the global submissions for Humira in psoriasis, patients are closer to gaining a biologic treatment option that may provide clearance from painful and disfiguring skin lesions," said Alan Menter, chairman of the division of dermatology at Baylor University Medical Center, Dallas. "We expect that patients living with psoriasis, their families and their health care providers will welcome the results from Humira clinical trials and the convenience of a self-administered injection."
In Reveal, a pivotal 52-week trial, the short-term and sustained clinical efficacy and safety of Humira were evaluated in more than 1,200 patients from the United States and Canada with moderate to severe chronic plaque psoriasis. Patients experienced a significant reduction in the signs of their disease at 16 weeks when treated with Humira.
Humira is the only fully human monoclonal antibody approved for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in the United States and Europe.