By Sneha S K and Kunal Das
Feb 20 (Reuters) – The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals’ drug for the treatment of two serious mental health conditions, the company said on Friday, sending its shares surging 30% in extended trading.
The drug, branded as Bysanti, is an antipsychotic pill aimed at treating schizophrenia and acute bipolar I disorder.
Bysanti, chemically known as milsaperidone, belongs to a class of drugs known as atypical antipsychotics that work by blocking dopamine and serotonin receptors in the brain, which help regulate mood, stress, delusions and alertness.
Schizophrenia is a serious mental illness that can cause hallucinations and delusions, while bipolar disorder is marked by dramatic shifts in mood and energy that can disrupt sleep, judgment and daily functioning.
Vanda said it expects to launch the drug in the U.S. in the third quarter.
The approval adds another psychiatric drug to Vanda’s portfolio. Fanapt, chemically known as iloperidone, is already approved in the U.S. for the same conditions.
Vanda has said that studies indicate milsaperidone changes into iloperidone soon after being absorbed in the body, and that patients end up with similar drug levels whether they take milsaperidone or iloperidone. Its safety profile is similar to that of iloperidone, Vanda said.
Bristol Myers Squibb’s Cobenfy for schizophrenia and Johnson & Johnson’s Caplyta for schizophrenia and bipolar I or II depression are among other approved antipsychotics.
Vanda is also studying the drug as a once-daily add-on treatment for major depressive disorder, with results expected later this year.
Jefferies analyst Andrew Tsai, ahead of the approval, said it will be interesting how Bysanti sales will shape up, given it is “essentially more or less the same drug with similar efficacy and safety” as Fanapt. He added it raises the question of why patients would choose Bysanti, especially if Fanapt goes generic around late 2027 or 2028.
Tsai models Bysanti sales of about $200 million by 2033.
(Reporting by Kunal Das and Sneha S K in Bengaluru; Editing by Maju Samuel)
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