Abbott's HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
Abbott has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA® (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis, an autoimmune disease characterized by skin lesions that are sometimes painful and itchy.
HUMIRA has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
USFDA has approved HUMIRA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of joint structural damage, and improving physical function in adult patients with moderately to severely active RA.
The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 of treatment versus placebo. HUMIRA has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn's disease in 2007.
Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. Psoriasis is a serious, sometimes painful autoimmune disease resulting in inflamed, scaly, red skin lesions known as plaques, which may crack and bleed.
The safety profile of HUMIRA in the plaque psoriasis clinical trials was similar to that seen in HUMIRA clinical trials for rheumatoid arthritis (RA). The most commonly reported adverse events in HUMIRA psoriasis trials were upper respiratory tract infection, nasopharyngitis (inflammation of the nose and pharynx), headache, sinusitis and arthralgia. HUMIRA is self-administered as an injection. Patients are treated with an initial 80 mg dose of HUMIRA (two 40 mg injections) followed by one HUMIRA injection (40 mg) one week later. After that, a maintenance dose of 40 mg is administered every other week.