FDA Expands ENBREL Psoriatic Arthritis Indication

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FDA Expands ENBREL Psoriatic Arthritis Indication

01 Jun 2005

Amgen Inc and Wyeth Pharmaceuticals, a division of Wyeth, today

announced that the US Food and Drug Administration (FDA) approved an

expanded indication for Enbrel® (etanercept) to improve physical

function in patients with psoriatic arthritis. ENBREL is the first and

only treatment to receive this expanded indication. In addition, the

FDA approved an update to the ENBREL label to include new radiographic

data demonstrating that ENBREL continued to inhibit the progression of

joint destruction for two years among most psoriatic arthritis patients

who received ongoing therapy.

ENBREL received its approval to treat signs and symptoms of psoriatic

arthritis in 2002. With this expanded approval, ENBREL is now indicated

for reducing signs and symptoms, inhibiting the progression of joint

destruction of active arthritis associated with psoriatic arthritis,

and improving physical function in patients with psoriatic arthritis.

ENBREL is also approved to treat moderate-to-severe rheumatoid

arthritis and juvenile rheumatoid arthritis, ankylosing spondylitis and

moderate-to-severe plaque psoriasis.

" This approval for improving physical function and the addition of the

two-year radiographic data builds on the well-established efficacy and

safety profile of ENBREL in psoriatic arthritis. No other treatment has

been FDA-approved to provide efficacy for psoriatic arthritis patients

using these multiple clinical measures, " said Will Dere, M.D., chief

medical officer and senior vice president of global development, Amgen.

" ENBREL is unique because it has received 10 FDA approvals in five

distinct diseases and has been used by more than 280,000 patients

worldwide across indications. ENBREL also has 12 years of collective

clinical experience. "

The expanded approval of ENBREL was based on significant improvements

in physical function as assessed by the disability index of the Health

Assessment Questionnaire (HAQ), a test used to evaluate a patient's

ability to perform daily activities such as dressing, walking and

grooming, and the Medical Outcomes Study Short-Form Health Survey

(SF-36), a measurement tool that also assesses the physical impact of a

disease.

Almost 40 percent of psoriatic arthritis patients taking ENBREL in this

study achieved a HAQ score of zero, indicating no functional disability

at 24 weeks. In addition, the SF-36 found that many patients treated

with ENBREL experienced a greater improvement from baseline, compared

to placebo, in their ability to participate in physical activities such

as walking, carrying groceries, or climbing a flight of stairs.

Psoriatic arthritis is a chronic, often destructive disease

characterized by both joint inflammation and erosion, and is associated

with psoriatic skin lesions. The progressive joint pain and swelling,

which is often coupled with painful, scaly, red skin lesions, can

disrupt a person's ability to perform activities of daily life that

most people take for granted such as getting dressed, eating or

walking. Approximately one million people suffer from psoriatic

arthritis in the United States.

" We are pleased that ENBREL has shown the ability to inhibit the

progression of joint destruction for a continuous two years in most

psoriatic arthritis patients in this study, which is vital in helping

to ease the debilitating effects of this disease, " said L. Stiles,

M.D., executive vice president and chief medical officer of Wyeth

Pharmaceuticals. " Similar to rheumatoid arthritis, ENBREL is the only

treatment approved to provide long-term inhibition of joint destruction

for most patients. "

ABOUT ENBREL

ENBREL is the only soluble tumor necrosis factor (TNF) receptor

approved to reduce signs and symptoms, induce major clinical response,

improve physical function, and inhibit the progression of structural

damage in patients with moderately to severely active rheumatoid

arthritis (RA). ENBREL can be used alone or in combination with

methotrexate.

ENBREL is the only treatment indicated to reduce the signs and

symptoms, inhibit the progression of structural damage of active

arthritis, and improve physical function in patients with psoriatic

arthritis. It is approved to reduce the signs and symptoms of

moderately to severely active polyarticular-course juvenile rheumatoid

arthritis (JRA) in patients four years of age or older who have had an

inadequate response to one or more disease-modifying antirheumatic

drugs (DMARDs). It is also the first biologic approved to reduce the

signs and symptoms in patients with active ankylosing spondylitis (AS).

ENBREL is indicated for the treatment of adult patients (18 years or

older) with chronic moderate-to-severe plaque psoriasis who are

candidates for systemic therapy or phototherapy.

ENBREL has been used by more than 280,000 patients worldwide across

indications.

ENBREL acts by binding TNF, one of the dominant inflammatory cytokines

or regulatory proteins that play an important role in both normal

immune function and the cascade of reactions involved in the

inflammatory process of RA, JRA, psoriasis, psoriatic arthritis, and

AS. The binding of ENBREL to TNF renders the bound TNF biologically

inactive, resulting in significant reduction in inflammatory activity.

What important information do I need to know about taking ENBREL?

ENBREL is a type of protein called a tumor necrosis factor (TNF)

blocker that blocks the action of a substance your body's immune system

makes called TNF. People with an immune disease, such as rheumatoid

arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis,

have too much TNF in their bodies. ENBREL can reduce the amount of TNF

in the body to normal levels, helping to treat your disease. But, in

doing so, ENBREL can also lower the ability of your immune system to

fight infections.

All medicines have side effects, including ENBREL. Possible side

effects of ENBREL include:

-- Serious infections

-- Many occurred in people prone to infection, such as those with

advanced or poorly controlled diabetes

-- Some serious infections have been fatal

-- Rare cases of tuberculosis have occurred

-- What not to do

-- Do not start ENBREL if you have an infection or are allergic to

ENBREL or its components

-- What to do

-- Tell your doctor if you are prone to infection

-- Stop ENBREL if a serious infection occurs

-- Contact your doctor if you have questions about ENBREL or develop an

infection

-- Tell your doctor if you have ever been treated for heart failure

-- Serious nervous system disorders such as multiple sclerosis,

seizures, or inflammation of the nerves of the eyes

-- Tell your doctor if you have ever had any of these disorders or if

you develop them after starting ENBREL

-- Rare reports of serious blood disorders (some fatal)

-- Contact your doctor immediately if you develop symptoms such as

persistent fever, bruising, bleeding, or paleness

-- In medical studies of all TNF blockers, including ENBREL, a higher

rate of lymphoma (a type of cancer) was seen compared to the general

population. The risk of lymphoma may be up to several fold higher in

rheumatoid arthritis and psoriasis patients

-- The role of TNF blockers, including ENBREL, in the development of

lymphoma is unknown

-- ENBREL can cause injection site reactions.

Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in

North America. Wyeth markets ENBREL outside of North America. Immunex

Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.

Additional information about ENBREL, including full Prescribing

Information, can be found on the website sponsored by the companies at

www.ENBREL.com or by calling toll free 888-4ENBREL (888-436-2735).