US FDA approves Vanda's drug for treatment of bipolar disorder

[April 03, 2024]  (Reuters) -The U.S. FDA approved Vanda Pharmaceuticals' drug to treat manic and mixed episodes associated with a type of bipolar disorder, the company said on Tuesday, marking the second approval for the treatment.

Shares of the Washington, D.C.-based company jumped 16% after the bell.

Fanapt, which was initially approved in 2009 as a treatment for schizophrenia, faces a potential loss of exclusivity in 2027.

The decision could help revive prescriptions for Fanapt, which has seen sales declining in recent quarters due to increased competition.

With the approval, the drug can be used to treat adults with Bipolar I disorder, in which patients experience manic episodes that last at least seven days, or severe manic symptoms like extreme mood swings.

The approval is based on a late-stage trial in which the company's drug, chemically known as Iloperidone, helped reduce severity of core symptoms of mania when tested across 400 patients.

About 40 million people worldwide suffer from bipolar disorder, according to the World Health Organization.

Sales of Vanda's sleep disorder drug Hetlioz have also been falling due to increased competition from cheaper versions.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File Photo

Fanapt's sales fell 4.1% to $91 million in 2023, while sales of Hetlioz declined 37.3% to $100.2 million.

Both the drugs accounted for more than 99% of the company's total revenue last year.

(Reporting by Christy Santhosh and Vaibhav Sadhamta in Bengaluru; Editing by Maju Samuel)

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