Sunovion’s Latuda (lurasidone HCI) receives Health Canada approval to treat adolescents with schizophrenia.
Sunovion Pharmaceuticals Inc. announced that Health Canada approved the Supplemental New Drug Submission (SNDS) for Latuda (lurasidone HCI) for the management of the manifestations of schizophrenia in adolescents aged 15 to 17 years. Latuda is currently indicated in Canada for the management of the manifestations of schizophrenia and the acute management of depressive episodes associated with bipolar I disorder in adults.
“The expansion of Latuda’s indication in Canada to include adolescents with schizophrenia marks an important milestone for patients and families in need of new treatment options for this difficult-to-manage condition,” said Antony Loebel, M.D., executive vice president and chief medical officer at Sunovion, head of global clinical development for Sumitomo Dainippon Pharma Group. “We are pleased that Latuda can now be considered for use in Canada for adolescent as well as adult patients with schizophrenia.”
The approval is based on results from a randomized, double-blind, placebo-controlled, six-week study in which adolescent patients with schizophrenia received fixed doses of Latuda 40 mg/day, Latuda 80 mg/day or placebo. At study endpoint, patients treated with Latuda 40 mg/day and 80 mg/day demonstrated statistically significant and clinically meaningful improvement in symptoms of schizophrenia compared to placebo. Latuda was also generally well tolerated with limited effects on weight and metabolic parameters.
In addition, Health Canada in June 2017 accepted for review, but has not yet approved, the SNDS for the expanded use of Latuda in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy.
The bipolar depression SNDS is supported by data from a Phase 3 clinical study of children and adolescents (10 to 17 years of age), in which Latuda was associated with statistically significant and clinically meaningful improvement in depressive symptoms compared to placebo and was generally well-tolerated with few effects on weight and metabolic parameters.
“Bipolar depression and schizophrenia are chronic and disabling conditions that can be particularly challenging to diagnose and treat in younger patients,” said Len Cortese, M.D., medical director of the Toldo Neurobehavioural Institute at Hotel Dieu Grace Hospital in Windsor, Ontario. “These milestones are important to the mental health community in addressing the need for additional effective and well-tolerated treatment options to manage pervasive psychiatric illnesses.”
(Source: Business Wire)
