Abbott Seeks Psoriasis Indication For Humira
This article was originally published in The Pink Sheet Daily
Executive Summary
The TNF inhibitor would join J&J’s Remicade and Wyeth’s Enbrel with an indication for the treatment of chronic plaque psoriasis.
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Abbott has submitted an sBLA seeking approval of Humira (adalimumab) for a fifth autoimmune disease indication for the treatment of moderate to severe chronic plaque psoriasis, the company announced April 2. Abbott is anticipating a standard 10-month review for the indication, which would give the firm an action date likely early in 2008. An approval for psoriasis would put Humira on even footing with competing tumor necrosis factor inhibitors such as Johnson & Johnson's Remicade (infliximab) and Amgen/Wyeth's Enbrel (etanercept), which are both approved for the treatment of plaque psoriasis. Enbrel is approved for chronic moderate to severe plaque psoriasis, while Remicade is indicated for chronic severe plaque psoriasis. All three biologics are already approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Humira and Remicade have additional indications for Crohn's disease, while Remicade is also approved for ulcerative colitis. Humira cleared FDA for the Crohn's indication in February (1 (Also see "Humira Clears FDA As First Self-Administered Biologic For Crohn’s Disease" - Pink Sheet, 27 Feb, 2007.)). During Abbott's fourth quarter sales and earnings call in January, the company predicted that Crohn's disease and psoriasis would be two of Humira's largest markets following rheumatoid arthritis, generating peak sales of $500 million in each indication (2 (Also see "Abbott Targets Simcor Filing For First Half 2007" - Pink Sheet, 24 Jan, 2007.)). Abbott simultaneously submitted an application to the European Medicines Agency seeking approval for the psoriasis indication for Humira, the company reported. The filings are based on the results of two double-blind, placebo-controlled trials of Humira, REVEAL and CHAMPION, evaluating the biologic based on the Psoriasis Area and Severity Index Score. The 52-week REVEAL study evaluated more than 1,200 patients with moderate to severe chronic plaque psoriasis. Patients experienced a significant reduction in the signs of their disease at 16 weeks following treatment with Humira, according to Abbott. Of those receiving the biologic, 71 percent achieved PASI 75 or better compared to only 6.5 percent of patients on placebo. Twenty percent of patients treated with Humira achieved PASI 100 (complete clearance), compared to 1 percent of patients on placebo. In CHAMPION, a 16-week study evaluating 271 patients, 80 percent of patients treated with Humira achieved PASI 75 compared to 36 percent of patients treated with methotrexate. Nearly 17 percent of patients treated with Humira achieved PASI 100 at week 16 compared to 7 percent of patients receiving methotrexate, the company reported. Adverse events observed in the trials were similar to those seen in previous trials with Humira, including upper respiratory tract infection, nasopharyngitis (inflammation of the nose and pharynx) and headaches. -Jessica Merrill ([email protected]) |