Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy. Ixekizumab is designed to specifically target IL-17A, a protein that plays a key role in driving underlying inflammation in psoriasis.
This is the first regulatory step toward approval for ixekizumab in Europe. The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the EU. The Commission usually makes a decision on marketing authorization within two to three months of the CHMP issuing its recommendation.
Psoriasis is a chronic autoimmune disease that affects the skin. Psoriasis affects 125 million people worldwide, approximately 20 percent of whom have moderate-to-severe plaque psoriasis. Plaque psoriasis is the most common form of the condition and appears as raised, red patches of skin covered with a silvery, white buildup of dead skin cells, which are often painful or itchy. The exact cause of psoriasis is unknown, though genetics and environmental factors are known to play a role in the development of the disease. In addition to physical symptoms, psoriasis can have a significant impact on an individual's quality of life and has been associated with an increased risk of other serious health conditions, including diabetes and heart disease.
"Psoriasis is a serious, chronic disease that can also have a significant, and sometimes debilitating, psychological and social impact," said Andrew Hotchkiss, president of Lilly's European and Canadian operations. "This CHMP positive opinion is a significant milestone in our quest to offer physicians a new treatment option for their patients with moderate-to-severe plaque psoriasis."
The CHMP positive opinion for ixekizumab was based on findings from the largest Phase 3 trial program in moderate-to-severe plaque psoriasis evaluated by regulatory authorities to date. This clinical program included three double-blind, multicenter, Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—which demonstrated the safety and efficacy of ixekizumab in more than 3,800 patients in 21 countries with moderate-to-severe plaque psoriasis. All three studies evaluated the safety and efficacy of ixekizumab (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.
In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician's Global Assessment (sPGA) 0 or 1. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a required measure the FDA uses to evaluate effectiveness.