Enbrel Approved by FDA Panel for Kids with Psoriasis

By Alice Turner
18:08, June 20th 2008
133 votes
Vote this story

A Food and Drug Administration advisory panel said Wednesday that wider use of Amgen Inc’s biologic drug Enbrel should be permitted to treat psoriasis in children.

Enbrel’s benefits and risks were the center of discussions for the advisory committee, who had to take into consideration the risk of serious infections and cancer.

The panel was divided between fully supporting Amgen’s request to market the drug for youth with moderate to severe forms of the skin disease and limiting its use to treat moderate to severe plaque psoriasis in children and teens who have not responded to other psoriasis treatments.

In conclusion, the committee voted for the second option.

If approved, Enbrel would be the first treatment approved in the U. S. for children with psoriasis, a dermatological disease which causes scaly patches of red, inflamed skin, a chronic recurring condition which is difficult to treat once and for all.

The Wyeth co-marketed drug is already approved to treat arthritis in adults and children. The injectable drug has been used to treat rheumatoid arthritis in adults since 1999. It was later approved to treat juvenile rheumatoid arthritis and other conditions in children aged 2 and older.

The agency will take into consideration the panel’s advice before making a final decision. It generally follows its panel’s advice.

The FDA previously announced that it would investigate whether the use of Enbrel, Remicade, Humira, and Cimzia, all of them tumor necrosis factor (TNF) inhibitors, are linked to cancers in about 30 children and young adults.

Last month, Enbrel received a “black box” warning concerning the risk of serious infections that may lead to hospitalization or death. The drug’s label warns patients and doctors about tuberculosis, bacterial sepsis and other infections in patients treated with Enbrel.



© 2007 - 2009 - eFluxMedia
dotclear

Other News in

dotclear
Latest videos in Health
Red wine 'could cause cancer'
Celebs strut for heart health
Pope Talks to Pelosi on...
Cuba's doctors set the...
All Peanut Items Recalled...

dotclear
Health You are here: Health
» Science   » Health   
E-mail To A Friend Print RSS Text size: Decrease font size Increase font size
dotclear
dotclear
dotclear

Interested In This Topic?

News Alert will keep you informed. Find out more.
dotclear
Photos Gallery
dotclear