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Takeda (TSE:4502/NYSE:TAK) announced that ORZEYFUL™ (oveporexton) CIV is now available in the U.S. by prescription for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults, bringing the first and only orexin agonist to this community. Learn more at ORZEYFUL.com.
“Living with narcolepsy type 1 is an ongoing struggle to keep it together - from scheduling naps and anticipating sleep attacks to figuring out how to be present as a mom and a professional,” said Emily P., clinical trial participant with NT1. “With ORZEYFUL, I feel more confident planning my day because my narcolepsy has become more manageable.”
Driven by orexin deficiency, the persistent 24-hour nature of NT1 affects far more than daytime sleepiness; it shapes how people plan their days and navigate many parts of their lives. What others might do without thinking can require careful planning, endless calculations and constant balancing to get through the day. Now, for the first time, people living with NT1 have a new option that targets the underlying orexin deficiency to treat the disease holistically rather than individual symptoms.
“Clinical trials showed ORZEYFUL improved the full range of symptoms, and now we can bring those results into real-world practice,” said Dr. Emmanuel Mignot, M.D., Ph.D., principal U.S. investigator in the ORZEYFUL Phase 3 program. “Using ORZEYFUL to target the underlying cause of narcolepsy type 1 is a welcome and exciting development in sleep medicine. I can now start a new conversation with my patients about their symptoms and how using this new treatment approach may make a real difference for them.”
“We work for decades toward the defining moments that have the potential to make a real difference for patients,” said Rhonda Pacheco, president of Takeda’s U.S. Business Unit. “Bringing ORZEYFUL, a first-in-class medicine, to people living with narcolepsy type 1 in the U.S. is one of those moments. We’re incredibly proud to be here, and equally focused on what comes next: supporting care and access for patients prescribed ORZEYFUL.”
ORZEYFUL is available by prescription from a licensed healthcare providers and will be dispensed across the U.S. through Accredo Specialty Pharmacy, part of Evernorth Health Services. Takeda offers patient support programs to help eligible adult patients prescribed ORZEYFUL get started, including help understanding coverage steps and connecting to available assistance options. For more information about ORZEYFUL, including prescribing information and available patient support visit ORZEYFUL.com.
About Narcolepsy Type 1 (NT1, narcolepsy with cataplexy), an Underdiagnosed Neurological Disease
NT1 is a rare, chronic neurological disease driven by a loss of orexin that affects an estimated 3 million people worldwide and 120,000 in the U.S. NT1 is characterized by excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), cognitive symptoms and disrupted nighttime sleep that can severely impact daily life, including work, education and social relationships.
More than half of treated NT1 patients remain symptomatic. NT1 also remains significantly underdiagnosed, with only an estimated 50% diagnosed in the U.S., a process that can take an average of 10 years. This diagnostic gap is partly due to symptom overlap with other sleep-wake and comorbidity disorders as well as the limited availability of easy-to-use diagnostic tools. Takeda is working to potentially address these challenges through development of biomarker solutions and digital tools that support earlier identification and differentiation of NT1.
