Sunovion’s new drug application for Latuda earns FDA review

Sunovion’s application was supported by results from a Phase 3 clinical study involving subjects ages 10 to 17.
Sunovion’s application was supported by results from a Phase 3 clinical study involving subjects ages 10 to 17. | Contributed image

Sunovion Pharmaceuticals Inc.'s supplemental New Drug Application (sNDA) for a medication addressing bipolar conditions has won acceptance for review by the U.S. Food and Drug Administration.

Latuda (lurasidone HCI), which Sunovion seeks to include for treatment of depressive symptoms of bipolar I disorder in children and adolescents between the ages of 10 and 17, is already indicated in the U.S. to treat adults, either by itself or in combination with lithium or valproate, for bipolar depression; and for adults and adolescents ages 13 to 17 for schizophrenia.

“Bipolar depression is a severe and disabling condition, yet few treatment options are available for children and adolescents with this disorder,” Dr. Antony Loebel, executive vice president and chief medical officer at Sunovion, said. “We look forward to working closely with the FDA toward the goal of offering a new treatment option for this difficult to treat condition.”

Sunovion’s application was supported by results from a Phase 3 clinical study involving subjects ages 10 to 17 in which Latuda was demonstrated to correlate with significant improvement. Additionally, it was reported to be well-tolerated with no substantial effects on metabolic function or weight.

Bipolar disorder affects approximately 12.6 million U.S. adults with over half (50 to 60 percent) first experiencing symptoms in adolescence. Additionally, it is the fourth top cause of disability in children and adolescents globally, Sunovion spokespersons noted.

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Organizations in this story

Sunovion Pharmaceuticals Inc. 84 Waterford Dr Marlboro, MA - 01752