CHMP Recommends Approval of New Indication for Enbrel(R) as Treatment for Severe Psoriasis in Paediatric Patients

Maidenhead, England, November 21 (ots/PRNewswire) -

- Not for UK Journalists

The European Committee for Medicinal Products for Human Use
(CHMP) today announced its positive recommendation for the approval
of Enbrel(R) (etanercept) as a treatment for children aged 8 years
and over and adolescents with severe plaque psoriasis. If approved by
the European Commission, following the Committee's recommendation,
Enbrel will become the first biologic treatment indicated for severe
psoriasis in children and adolescents. Enbrel is currently approved
in the European Union for the treatment of moderate-to-severe plaque
psoriasis in adults, as well as for ankylosing spondylitis, psoriatic
arthritis, moderate to severe rheumatoid arthritis (RA) in adults,
and polyarticular juvenile idiopathic arthritis (JIA) in children.(1)

"Psoriasis can be a distressing disease at any age," said Stevo
Knezevic, MD, PhD, Chief Medical Officer of Wyeth Europa. "A third of
psoriasis patients first see signs of the disease well before the age
of 16 and there are currently limited effective treatment options
available with approved dosing regimens for children and adolescents.
We are, therefore, encouraged by the positive recommendation from the
CHMP for the approval of Enbrel(R) for use in the paediatric
population."

The recommendation by the CHMP is based on results from the first
randomised placebo-controlled trial of a biologic treatment in
children aged 17 and under (study 211). Results from the study showed
that patients treated with Enbrel experienced a significant
improvement of their plaque psoriasis compared to those treated with
placebo. There were no serious adverse events or serious infections
during the 12-week placebo-controlled period and rates of adverse
events were similar for Enbrel and placebo.

Impact of Psoriasis

Across Europe, 5.1 million people are estimated to have
psoriasis(2), a distressing chronic inflammatory disease.
Approximately 80 per cent of these patients have plaque psoriasis,
which is characterised by red, scaly patches.(3) Psoriasis can be
extremely distressing, and may have a significant impact on patients'
quality of life. It is a condition which is frequently physically and
psychologically disabling.(4)

Currently, treatments for children and adolescents with psoriasis
are mainly limited to topical medications that are applied directly
to the skin. Whilst these treatments may be effective at reducing the
visible skin lesions and associated symptoms, they are generally used
for mild and moderate forms of paediatric psoriasis.

Enbrel is an innovative drug that works by reducing the chronic
inflammation that leads to plaque psoriasis.

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Notes To Editors

"The 211 study: Enbrel(R) in children and adolescents(5)

The 48 week study involved 211 patients with moderate-to-severe
psoriasis aged four to 17 years. During the first 12 weeks of the
trial, patients received once weekly injections of either placebo or
0.8 mg of Enbrel per kilogram of body weight up to a maximum of 50
mg. For the next 24 consecutive weeks, all patients went on to
receive Enbrel. The 138 patients still participating at week 36 were
then re-randomised to receive either placebo or Enbrel in order to
investigate whether stopping treatment would lead to any rebound.

At week 12, almost two-thirds of patients (57%) achieved a 75%
improvement in the psoriasis area-and-severity index (PASI 75),
compared to 11% of patients receiving placebo. At week 36, after 24
weeks of open-label Enbrel, 68% of patients in the Enbrel-Enbrel
group and 65% of patients in the placebo-Enbrel group achieved PASI
75. During the treatment withdrawal period, 42% of patients receiving
placebo instead of Enbrel, lost their response to treatment. There
were no cases of rebound or change in psoriasis morphology from
plaque to, for example, guttate or pustular psoriasis).

There were no serious adverse events or serious infections during
the 12-week placebo-controlled period and rates of adverse events
were similar for Enbrel and placebo. During open-label treatment,
three patients developed four serious adverse events. No deaths,
cancers, opportunistic infections, tuberculosis or demyelination
events were reported. The most common adverse events observed during
the 48-week trial in patients treated with Enbrel were upper
respiratory tract infection, headache, and nasopharyngitis. After
allowing for the greater length of time Enbrel was administered, the
rates were seen to be numerically lower that those when the patients
were on placebo injections."

About Enbrel

Enbrel is a fully human soluble tumour necrosis factor (TNF)
receptor. Enbrel was first approved in 1998 for moderate to severe
rheumatoid arthritis and has since been used in nearly 500,000
patients worldwide across indications.

Enbrel in the EU is approved for the following indications:

Rheumatoid arthritis

Enbrel in combination with methotrexate is indicated for the
treatment of moderate to severe active rheumatoid arthritis in adults
when the response to disease-modifying antirheumatic drugs, including
methotrexate (unless contraindicated), has been inadequate.

Enbrel can be given as monotherapy in case of intolerance to
methotrexate or when continued treatment with methotrexate is
inappropriate.

Enbrel is also indicated in the treatment of severe, active and
progressive rheumatoid arthritis in adults not previously treated
with methotrexate.

Enbrel, alone or in combination with methotrexate, has been shown
to reduce the rate of progression of joint damage as measured by
X-ray and to improve physical function.

Polyarticular juvenile idiopathic arthritis

Treatment of active polyarticular juvenile idiopathic arthritis
in children and adolescents aged 4 to 17 years who have had an
inadequate response to, or who have proved intolerant of,
methotrexate. Enbrel has not been studied in children aged less than
4 years.

Psoriatic arthritis

Treatment of active and progressive psoriatic arthritis in adults
when the response to previous disease-modifying antirheumatic drug
therapy has been inadequate. Enbrel has been shown to improve
physical function in patients with psoriatic arthritis, and to reduce
the rate of progression of peripheral joint damage as measured by
X-ray in patients with polyarticular symmetrical subtypes of the
disease.

Ankylosing spondylitis

Treatment of adults with severe active ankylosing spondylitis who
have had an inadequate response to conventional therapy.

Plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who
failed to respond to, or who have a contraindication to, or are
intolerant to other systemic therapy including cyclosporine,
methotrexate or PUVA

About Wyeth:

Wyeth is one of the world's largest research-based pharmaceutical
and health care products companies. It is a leader in the discovery,
development, manufacturing, and marketing of prescription drugs and
over-the-counter medications. It is also a global leader in vaccines,
biotechnology and animal health care.

References
1. Enbrel EMEA SPC.
http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-en.pdf
2. Christophers E. Psoriasis - Epidemiology and Clinical Spectrum. Clin
Exp Dermatol 2001;26:314-320
3. National Psoriasis Fund. Plaque Psoriasis.
http://www.psoriasis.org/about/psoriasis/plaque.php . Accessed October
2008
4. Mrowietz, U et al. The importance of disease associations and
concomitant therapy for the long-term management of Psoriasis patients
Arch Dermatol Res (2006)
5. Paller, AS et al. Etanercept treatment for children and adolescents
with plaque psoriasis. N Engl J Med 2008;358:241-51

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

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.