FDA Approves Enbrel for Psoriasis
Third Biologic Drug Approved for Treatment of Psoriasis
May 3, 2004 -- Enbrel now joins Amevive and Raptiva as one of the first biologic drugs to be approved for the treatment of psoriasis.
The FDA approved Enbrel on April 30 for the treatment of adults 18 and older with chronic, moderate to severe psoriasis. Psoriasis is an incurable skin condition in which the immune system malfunctions and causes skin cells to regenerate too quickly, causing inflamed, scaly patches that itch, crack, and bleed.
Until recently, there were few treatment options for people with the chronic skin condition, but the development of biologics, drugs that are created from proteins produced by living cells, has provided new alternatives. Last year, the FDA approved the first two biologics for psoriasis, Amevive and Raptiva.
Enbrel is already approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
The drug is delivered by injection, and the FDA approved a twice-weekly dose of 50 mg for the first three months of psoriasis treatment followed by a maintenance dose of 50 mg per week thereafter.
Enbrel Approved for Psoriasis
The FDA approval was based on the results of two phase III clinical trials involving 1,200 adults with psoriasis who were treated for up to 12 months.
The studies showed nearly half (46%) of those who received Enbrel had a 75% or greater improvement on the Psoriasis Area Severity Index after three months of treatment. That response was sustained for an additional three months at the lower dose.
"Enbrel targets a specific protein that produces an inflammatory response in both psoriasis and psoriatic arthritis," says Craig Leonardi, MD, clinical associate professor of dermatology at Saint Louis University and a member of the Psoriasis Foundation's medical board, in a news release.
In psoriasis, the release of a protein called tumor necrosis factor (TNF) causes the inflammation and painful patches on the skin. Enbrel acts as an anti-TNF therapy.
"Throughout the trials, patients had impressive, safe, and consistent responses to Enbrel therapy. Having an established record in treating psoriatic arthritis, Enbrel is now the first of the new biologic drugs to treat the full spectrum of psoriatic disease," says Leonardi.
The most common side effects associated with Enbrel are injection site reactions.
Amgen Inc. and Wyeth Pharmaceuticals jointly produce Enbrel. Both companies are WebMD sponsors.