Tasimelteon

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 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.

Pictured: FDA's signage outside its office in Maryland/iStock, hapabapa The FDA on Tuesday approved the use of Vanda Pharmaceuticals’ atypical antipsychotic Fanapt (iloperidone) for the treatment of manic or mixed episodes in adult patients with bipolar I disorder. Vanda’s shares jumped 33% in post-market trading in reaction to the news, according to MarketWatch. Vanda CEO Mihael Polymeropoulos in a statement said that Tuesday’s approval “gives patients and service providers a new treatment for managing bipolar I disorder.” “Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile,” Polymeropoulos said, adding that the drug has accrued more than 100,000 patient-years of experience since its approval in 2009. Afflicting around 2.8% of U.S. adults, bipolar disorder is a serious psychiatric condition characterized by having periods of depressed mood alternating with periods of high mood. Mania in bipolar disorder refers to feelings of euphoria and having excessive energy, or feeling unusually irritable. Mixed episodes, on the other hand, are defined by symptoms of both mania and depression, either felt simultaneously or in quick succession. More than 80% of bipolar cases are classified as severe, according to Vanda. Fanapt is an atypical antipsychotic that was first approved in 2009 for the treatment of schizophrenia in adults. Its exact mechanism of action is still unknown, according to its label, though Vanda proposes that Fanapt blocks the dopamine type 2 and serotonin type 2 receptors. The FDA’s approval on Tuesday is backed by data from a Phase III clinical trial that enrolled around 400 patients with a history of bipolar I disorder. Participants were currently suffering from a manic episode. After four weeks of treatment, patients treated with Fanapt showed significantly greater improvements in the Young Mania Rating Scale, a tool to assess the severity of mania, versus placebo. The trial also found that Fanapt could elicit rapid benefits in bipolar I disorder, with its significant superiority over placebo becoming apparent as early as two weeks after treatment initiation. Tuesday’s regulatory victory will help Vanda recoup after the FDA last month rejected its melatonin receptor blocker Hetlioz (tasimelteon) for the treatment of insomnia. The rejection is in connection with an earlier notification from the regulator, informing Vanda that it had found problems “that preclude discussion of labeling and postmarketing requirements/commitments at this time.” Vanda has not yet made public what these deficiencies are and the company is currently evaluating its next steps for Hetlioz. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.