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FDA Approves ORZEYFUL for Adults With Narcolepsy Type 1

takeda.com · 2,395 words · saved by 1 readers

Takeda announces FDA approval of ORZEYFUL, a first-in-class oral orexin treatment for adults with narcolepsy type 1, pending DEA scheduling.

Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical Trials Compared to Those on Placebo As a First-in-Class Orexin Treatment, ORZEYFUL has the Potential to Redefine NT1 Care Beyond Individual Symptoms Takeda is Advancing U.S. Launch Preparations and Expects to Make ORZEYFUL Available Following Completion of the Drug Enforcement Administration (DEA) Scheduling Process OSAKA, Japan and CAMBRIDGE, Massachusetts, August 5, 2026 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug…

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