Humira Cleared For Additional Psoriatic Arthritis Indication
This article was originally published in The Pink Sheet Daily
Executive Summary
Broadened indication for inhibiting structural joint damage matches Enbrel and Remicade indications.
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Abbott's TNF inhibitor Humira (adalimumab) will compete against Johnson & Johnson's Remicade (infliximab) and Wyeth's Enbrel (etanercept) in an expanded psoriatic arthritis indication. The company announced the FDA approval Nov. 14. Humira's updated labeling states that it is indicated for "reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis." Humira can be used alone or in combination with other disease-modifying anti-rheumatic drugs in the expanded indication. The expansion is based on results from a 24-week open-label extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) involving 285 patients. Patients were randomized to receive either Humira 40 mg every other week or placebo. The study showed that more than three times as many patients on placebo (29%) experienced joint damage compared to patients taking Humira (9%) at week 24; results in the Humira patients were maintained through 48 weeks, Abbott said. Both Enbrel and Remicade are approved for the same psoriatic arthritis indication. The three biologics also are approved for rheumatoid arthritis and ankylosing spondylitis (1 (Also see "Humira To Compete With Remicade, Enbrel in Ankylosing Spondylitis" - Pink Sheet, 31 Jul, 2006.)). In addition, Enbrel is indicated for juvenile RA and plaque psoriasis; and Remicade is also indicated for plaque psoriasis, ulcerative colitis and both adult and pediatric Crohn's disease. Abbott announced on Sept. 7 that it had submitted a supplemental BLA for use of Humira in treatment of Crohn's disease (2 (Also see "Crohn’s Competition Coming" - Pink Sheet, 7 Sep, 2006.)). FDA recently granted the application a priority six-month review, the company told "The Pink Sheet" DAILY. The company remains on track to submit an sBLA for juvenile RA in 2007. Humira already had its foot in the door of the dermatology space with an initial PsA "signs and symptoms" FDA approval for Humira, received in October 2005 (3 (Also see "Abbott's Humira Approved For Psoriatic Arthritis, First-Line Rheumatoid Arthritis" - Pink Sheet, 4 Oct, 2005.)). Abbott is on track to file a psoriasis sBLA for the biologic in the first half of 2007, with a goal of reaching the market with the indication in the first half of 2008, the company said. Abbott also recently initiated Phase III studies for Humira in pediatric Crohn's disease and ulcerative colitis. For 2006, sales of Humira are approaching $2 bil. worldwide, the company said. Sales for 2005 topped out at $1.4 bil. - Shirley Haley ([email protected]) |