After sustaining a regulatory defeat in insomnia, Vanda Pharmaceuticals on Tuesday won the FDA’s approval for its atypical antipsychotic Fanapt for the treatment of manic or mixed episodes in adults with bipolar I disorder.
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.
