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FDA approves Takeda’s first-in-class narcolepsy drug
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European Medical Journal
Takeda has secured FDA approval for the first drug to treat the underlying cause of narcolepsy type 1, with the company forecasting peak annual sales of between $2bn and $3bn as it seeks further regulatory approvals.
Known as Orzeyful (oveporexton), the therapy is an orexin receptor 2 agonist that restores a brain signal missing in people with narcolepsy type 1.
Narcolepsy is a chronic neurological disorder characterised by excessive daytime sleepiness, sudden muscle weakness known as cataplexy, sleep paralysis and vivid hallucinations.
For now, Orzeyful is approved only for adults with narcolepsy type 1 in the US.
The company expects to launch Orzeyful in the US in November, subject to scheduling by the Drug Enforcement Administration.