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
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.