Fast Track Abilify

 FDA grants priority to test antipsychotic drug for use by teens

(June 6, 2007) -- Bristol-Myers Squibb yesterday announced its application to market Abilify for schizophrenia to teenagers was granted priority review by the Food and Drug Administration.

If approved, it would keep Bristol-Myers in step with its competitors and expand the market for Abilify, whose sales last year surged 41 percent to $1.3 billion. 

Eli Lilly announced last month it received conditional approval to market its schizophrenia drug, Zyprexa, to adolescents. Johnson and Johnson's application has been pending since December to sell Risperdal, its schizophrenia and bipolar disorder therapy, to teens.

While no drugs are currently approved in the U.S. to treat schizophrenia in adolescents, all three medicines awaiting FDA approval, known as atypical antipsychotics, are widely prescribed off label for teenagers, despite concerns about side effects, including weight gain and involuntary movement syndromes.

Antipsychotics rang up $18.2 billion in sales last year, with Risperdal accounting for $4.6 billion of the total, according to IMS Health, a pharmaceutical information clearinghouse in the United Kingdom.

Schizophrenia causes distorted thinking, hallucinations and an inability to behave normally in social situations. It affects about 1 in every 100 people worldwide.

Robert Findling, the author of the Abilify study and professor of psychiatry at Case Western Reserve University in Cleveland, said in a telephone interview the expanded FDA indication would be the first treatment for "a very serious condition that is impairing for these children," and that "parents and patients want something."

Findling acknowledged schizophrenia was difficult to diagnose because "many symptoms of the condition" mimic other diseases.

Jeffrey Mattes, a psychiatrist in Princeton and chairman of the New Jersey Psychiatric Association's psychopharmacology committee, said "doctors will be wary about using these drugs in adolescents" because of the side effects and difficulty in making an accurate diagnoses.

"It's hard to say how useful it's going to be," Mattes said of the prospect of a new indication for teens. "There may be some (psycho-)analysts who do well with it, and other psychoanalysts who believe they are overused in adolescents."

Bristol-Myers' supplemental New Drug Application is based on data from a six-week study of 302 adolescent patients, ages 13 to 17, at 101 study sites in 13 countries. Findling said the study found Abilify was effective and well tolerated at doses of 10 milligrams and 30 milligrams for six weeks.

The FDA gives priority review to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The average time for priority review is six months, versus 14 months for a standard review, according to FDA figures.

Last year, the FDA approved all 12 applications granted priority review.

Abilify, first approved in 2002, is among seven atypical antipsychotics on the market for limited use in treating adults with schizophrenia and manic episodes of Bipolar I Disorder, also known as manic-depression, the most serious of all mental illnesses.

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The others include Clozaril, Zyprexa, Risperdal, Seroquel, Geodon and the newest, Invega, which was approved by the FDA in December.

Atypical antipsychotics are sometimes associated with diabetes, hyperglycemia and repetitive, involuntary, purposeless movements.

Mattes said adolescents might be "better off on mood stabilizers," such as lithium or several anti-convulsives, some FDA approved for behavior modification and others commonly used off-label. Findling said lithium and anti-convulsives are "not considered first-line treatments for schizophrenia."

By: George E. Jordan
Source: The Star Ledger

Last updated: 06/07

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