05-21-2005, 09:05 PM
Federal regulators rejected Johnson & Johnson's application to market its antipsychotic drug Risperdal for the treatment of autism.
Risperdal, Johnson & Johnson's No. 2 drug in sales last year, is approved by the Food and Drug Administration as a treatment for symptoms of schizophrenia. The New Brunswick-based company yesterday said it received a "not approvable" letter from the FDA, which means the agency believes the scientific data supporting the additional use is deficient.
Autism is a developmental disorder that surfaces in early childhood and has no known cure. As many as 500,000 people under the age of 21 suffer from the disability, according to the Centers for Disease Control and Prevention. Symptoms include repetitive behavior and difficulty talking or interacting well with others.
Doctors have used Risperdal to limit temper tantrums and other outbursts sometimes found in autistic children. A 2002 study in the New England Journal of Medicine, included in Johnson & Johnson's application, found the drug substantially reduced evaluations of irritability among its test group of 101 children. The study, however, noted the trial period was too short to draw conclusions about potential side effects.
A company spokesman, Doug Arbesfeld, declined to say what issues the FDA raised in its "not approvable" letter, which are typically considered proprietary.
"Recognizing the unmet need in this area is great, (Johnson & Johnson Pharmaceutical Research & Development) is evaluating the FDA's letter and will determine appropriate next steps," the company said in a statement.
Some analysts who follow Johnson & Johnson said they hadn't factored in Risperdal's approval for autism in their forecasts this year. The reaction on Wall Street was also muted; Johnson & Johnson shares fell less than 1 percent.
Risperdal, developed by the company's Janssen subsidiary in Titusville, has been one of Johnson & Johnson's great success stories. Last year, it accounted for $3.1 billion in sales, or 5 percent of the company's revenue.
http://www.nj.com/business/ledger/index....321600.xml
Risperdal, Johnson & Johnson's No. 2 drug in sales last year, is approved by the Food and Drug Administration as a treatment for symptoms of schizophrenia. The New Brunswick-based company yesterday said it received a "not approvable" letter from the FDA, which means the agency believes the scientific data supporting the additional use is deficient.
Autism is a developmental disorder that surfaces in early childhood and has no known cure. As many as 500,000 people under the age of 21 suffer from the disability, according to the Centers for Disease Control and Prevention. Symptoms include repetitive behavior and difficulty talking or interacting well with others.
Doctors have used Risperdal to limit temper tantrums and other outbursts sometimes found in autistic children. A 2002 study in the New England Journal of Medicine, included in Johnson & Johnson's application, found the drug substantially reduced evaluations of irritability among its test group of 101 children. The study, however, noted the trial period was too short to draw conclusions about potential side effects.
A company spokesman, Doug Arbesfeld, declined to say what issues the FDA raised in its "not approvable" letter, which are typically considered proprietary.
"Recognizing the unmet need in this area is great, (Johnson & Johnson Pharmaceutical Research & Development) is evaluating the FDA's letter and will determine appropriate next steps," the company said in a statement.
Some analysts who follow Johnson & Johnson said they hadn't factored in Risperdal's approval for autism in their forecasts this year. The reaction on Wall Street was also muted; Johnson & Johnson shares fell less than 1 percent.
Risperdal, developed by the company's Janssen subsidiary in Titusville, has been one of Johnson & Johnson's great success stories. Last year, it accounted for $3.1 billion in sales, or 5 percent of the company's revenue.
http://www.nj.com/business/ledger/index....321600.xml