Enbrel Approved by FDA Panel for Kids with Psoriasis

By Alice Turner
18:08, June 20th 2008
73 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 - 2008 - eFluxMedia
dotclear

Other News in

Melbourne Scientists Working On New Drug That May Help Insomniacs

Melbourne Scientists Working On New Drug That May Help Insomniacs

Sleep is a very important process in the human body, as it helps the body regenerate and leaves a person fresh and ready to start off on another day. Sleep deprivation, insomnia and even jet lag have...

The Pill That Makes Jet Lag Vanish

The Pill That Makes Jet Lag Vanish

An experimental drug promises to reset the body's internal clock and banish jet lag victims for good. Maryland-based Vanda Pharmaceuticals Inc. reported that the drug, Tasimelteon, works by mimicking...

Study Shows Autistic Children Face Difficulty Processing Sounds

Study Shows Autistic Children Face Difficulty Processing Sounds

According to a new study, children with autism spectrum disorder process sounds a fraction of a second slower than other children. This abnormality gives insight into issues of language and...

Epilepsy Drug in Pregnancy Increases Autism Risk

Epilepsy Drug in Pregnancy Increases Autism Risk

Pregnant women taking valproate, a drug used to treat epilepsy, may significantly increase their baby’s risk of developing autism, according to a study published in the Dec. 2 issue of the journal...

Media Exposure Is Bad For Kids’ Health, Study Says

Media Exposure Is Bad For Kids’ Health, Study Says

Parents, have you ever wondered how exposure to media sources impacts the physical health of your kids? A study by the US National Institutes of Health, Yale University and the California...

dotclear
Latest videos in Health
Drugmakers' recession...
Zimbabwe cholera death toll...
Doctor designs artificial...
Face to face best for baby...
Landmark windpipe transplant

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
Most Popular in Health
FDA Defends the Low Levels of Melamine In Baby FormulasFDA Defends the Low Levels of Melamine In Baby Formulas

» read full story
dotclear

Interested In This Topic?

News Alert will keep you informed. Find out more.
dotclear
Photos Gallery
dotclear
Today's Latest News
Melbourne Scientists Working On New Drug That May Help InsomniacsMelbourne Scientists Working On New Drug That May Help Insomniacs

» read full story
dotclear