Takeda Pharmaceutical Company Receives FDA Approval for ORZEYFUL, First Treatment for Narcolepsy Type 1

TOKYO, Aug 06 (Pulse News Wire) – Takeda Pharmaceutical Company Limited (4502.F) announced today that the US Food and Drug Administration (FDA) approved ORZEYFUL (obepepterson) for the treatment of narcolepsy type 1 (NT1). ORZEYFUL is designed to address NT1 caused by hypocretin deficiency, affecting an estimated 120,000 people in the US.

Clinical trials showed statistically significant improvements in symptoms compared to placebo. Approval marks a milestone for patients suffering from NT1, offering a new therapeutic approach beyond symptom management.

Takeda plans to launch ORZEYFUL in the US after DEA classification, expected within 90 days. The drug's approval does not significantly impact the company’s fiscal 2027 March quarter earnings forecast.