Sunovion cleared by FDA to offer depression drug to pediatric patients
Photo | Grant Welker
Sunovion's Marlborough headquarters
Marlborough drugmaker Sunovion has received federal approval for use of a bipolar depression treatment drug in pediatric patients.
The Food and Drug Administration approval of supplemental new drug application, announced by the company Tuesday, expands the use of the company’s trademark drug Latuda for use in pediatric patients aged 10 to 17 suffering from bipolar depression.
Currently, the drug is approved in the U.S. for bipolar depression for adults, and for schizophrenia patients aged 13 and above.
In a press release, Sunovion said the approval was supported by data from a six-week placebo-controlled clinical study showing the drug was statistically significant and clinically meaningful in improving bipolar depression symptoms compared to a placebo.
In a statement, Robert Findling, vice president of Psychiatric Services and Research at the Kennedy Krieger Institute, Director, Child & Adolescent Psychiatry at the Johns Hopkins University School of Medicine, said the drug is the first single-agent formulation to receive regulatory approval for pediatric patients.
David Frawley, executive vice president and chief commercial officer at Sunovion, called the FDA approval an important milestone for the mental health community.
“We are proud to build on the strong foundation of Latuda for adults with bipolar depression and to now be able to offer this medicine as a treatment option for pediatric patients living with this devastating condition,” he said.
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