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FDA approves sNDA for Latuda to treat adolescent schizophrenia
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Sunovion recently announced that the FDA approved a supplemental New Drug Application for Latuda for the treatment of schizophrenia in adolescents aged 13 to 17 years.
“We are pleased that Latuda’s range of indications has now expanded beyond the adult population to include the treatment of schizophrenia in adolescents aged 13 to 17 years. We believe that Latuda, as the first such medication in 5 years approved for adolescent patients with schizophrenia, is an important new treatment option for this difficult to treat illness,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in the release. “This approval builds on and reflects our commitment to advancing the treatment of serious psychiatric illness.”
The approval reflects positive results from a randomized, double-blind, placebo-controlled 6-week study among adolescents with schizophrenia. Study participants received fixed doses of 40 mg or 80 mg of Latuda (lurasidone, Sunovion Pharmaceuticals) or placebo.
At study endpoint, participants who received lurasidone exhibited statistical and clinical improvement in schizophrenia symptoms, compared with placebo.
Further, lurasidone was well-tolerated with limited effects on weight and metabolic parameters, according to the release.
“The impact on development and poor prognosis frequently associated with schizophrenia that begins in adolescence underscores the need for treatment that is both well-tolerated and effective,” study researcher Robert Findling, MD, MBA, of the Kennedy Krieger Institute and Johns Hopkins University School of Medicine, said in a press release. “The availability of Latuda provides health care providers with an important new option for helping adolescents with this illness that is chronic and severely disabling.”