UPDATED
From
HealthDay:
A U.S. Food and Drug Administration advisory panel voted overwhelmingly Wednesday that Seroquel and Zyprexa, two powerful antipsychotic drugs, be approved to treat schizophrenia and bipolar disorder in children aged 13 to 17.
The panel also endorsed Geodon, a third antipsychotic in the same class, as safe and effective for the treatment of bipolar mania in children aged 10 to 17.
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From
The Associated Press:
Advisers to the Food and Drug Administration are scheduled to vote Wednesday on whether three powerful psychiatric drugs should be approved for children, despite side effects that can increase the risk of diabetes.
A positive decision from FDA would expand the use of a class of drugs that accounted for more than $14.6 billion in sales last year, according to health care analysis firm IMS Health.
The FDA will ask its panel of psychiatric experts whether drugs from AstraZeneca PLC, Eli Lilly & Co. and Pfizer Inc. should be approved to treat schizophrenia and bipolar disorder in patients ages 10 to 17. The drugs already are approved to treat those conditions in adults.
On Tuesday, the companies each presented data from studies that lasted between three and six weeks and compared their drugs to placebo.
FDA officials told panelists the drugs appear to be effective for younger patients, though concerns remain about their side effects, including weight gain, high blood sugar and sleepiness.
Patient and consumer groups said the companies should have conducted more in-depth studies to look at the long-term effects of the medications.
The FDA on Wednesday will ask the 10 members of its psychiatric drug advisory committee to discuss the benefits and risks of each medication and then vote on whether it should be approved for younger patients.
The FDA is not required to follow the advice of its panels, though it usually does.
AstraZeneca and Lilly are seeking permission to market their drugs —
Seroquel and
Zyprexa, respectively — for adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pfizer is seeking approval to market its pill
Geodon for bipolar patients ages 10 to 17.
With only two anti-psychotic drugs currently approved for younger patients, a positive decision for the three drugs would significantly increase competition in the market for anti-psychotics — the top-selling class of prescription medications in the U.S. last year, according to IMS Health.
Currently, only Bristol-Myers Squibb's
Abilify and Johnson & Johnson's
Risperdal are approved for use in younger patients.