Vanda’s Fanapt clinches second FDA nod, this time for bipolar I disorder

2024-04-03

上市批准临床3期临床结果

The FDA cleared Vanda Pharmaceuticals’ Fanapt (iloperidone) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, marking the oral atypical antipsychotic’s second US approval following authorisation for schizophrenia in 2009.

"Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs,” said Vanda CEO Mihael Polymeropoulos, adding that Fanapt is a “therapeutic agent that offers flexible dosing with a well-known safety profile.”

The expanded label approval was based on findings from a Phase III study, in which 400 participants with bipolar I disorder experiencing a current episode of mania were randomly assigned to either Fanapt or placebo. At the four-week assessment, Fanapt demonstrated a significantly greater improvement than placebo on the primary endpoint of mania severity, as measured by the Young Mania Rating Scale (YMRS). Moreover, clinical benefits were evident in the Fanapt group as early as week two.

Vanda noted that Fanapt’s safety profile was consistent with its previous studies in schizophrenia. The drug’s label carries a boxed warning highlighting an increased risk of death in elderly patients with dementia-related psychosis.

Within its neuropsychiatric portfolio, Vanda is also looking to broaden the label for Hetlioz (tasimelteon), which was approved for non-24-hour sleep-wake disorder in 2014 and nighttime sleep disturbances associated with Smith-Magenis Syndrome in 2020. However, the melatonin receptor agonist melatonin receptor agonist was slapped with a complete response letter by the FDA for its label expansion in jet lag disorder in 2019 and more recently in insomnia.

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