The U.S. Food and Drug Administration has approved the Bristol-Myers Squibb antipsychotic drug Abilify (aripiprazole) for adolescents aged 13 to 17 diagnosed with schizophrenia, the company said Tuesday.
The FDA first approved the drug to treat schizophrenia in adults in November 2002. More than 12.5 million U.S. prescriptions for the medication have since been written, the drug maker said.
Expanded approval to teens was based on a six-week, 13-nation study that "demonstrated significant improvement with Abilify compared to placebo," a company statement said.
Read onThe first new class of drugs in more than a decade for treating schizophrenia worked at least as well in a clinical trial as standard medications, a study released Sunday showed.
Unlike current anti-psychotic drugs, which block the uptake of a naturally occurring chemical called dopamine, the new drug acts on a different neurotransmitter, glutamate.
The new treatment also reduced certain undesirable side-effects, according to the study, published in the British journal Nature Science.
Read onU.S. regulators said on Monday that Johnson & Johnson added new warnings to its schizophrenia drug, Haldol, about the potential risk of death and of dangerous heart conditions observed in some patients.
The U.S. Food and Drug Administration said new labeling on the drug will note that ailments, including QT prolongation, a disorder of the heart's electrical system that can lead to a life-threatening condition, have been observed in post-marketing studies.
The drug is also sold generically under the name haloperidol.
Several other drugs for schizophrenia, including a much newer J&J drug including Invega, have warnings about the risk of the serious cardiac effect.
Read onEli Lilly yesterday added strong warnings to the label of Zyprexa, its best-selling medicine for schizophrenia, citing the drug’s tendency to cause weight gain, high blood sugar, high cholesterol and other metabolic problems.
For the first time, Zyprexa’s label now acknowledges that the drug causes high blood sugar more than some other medicines for schizophrenia and bipolar disorder, called atypical antipsychotics.
Lilly previously argued that Zyprexa had not been proved to cause high blood sugar at a more frequent rate than its competitors.
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