Subjects ” sleep disorders
The Food and Drug Administration (FDA) has granted TAK-994 Breakthrough Therapy status for the treatment of excessive daytime sleepiness in patients with type 1 narcolepsy.
TAK-994 is an investigational oral orexin agonist designed to selectively target orexin-2 receptors. The company is currently investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-994 in adults with type 1 or type 2 narcolepsy in a Phase 2 study (ClinicalTrials.gov Identifier: NCT04096560). The data from the completed study will be presented at a future scientific conference.
“People with type 1 narcolepsy experience excessive daytime sleepiness, which can mean they routinely fall asleep at work or school,” said Sarah Sheikh, Head, Neuroscience Therapeutic Area Unit, Takeda. “If approved, the investigational drug TAK-994 has the potential to change the way we currently treat [narcolepsy type 1] by addressing the underlying orexin deficiency that is central to the disease. “
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The FDA’s fast-track status enables accelerated review of therapies designed to treat serious or life-threatening conditions. In general, the designation is given to therapies that are expected to influence factors such as survival and daily functioning.
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The US Food and Drug Administration has granted Takeda’s test compound TAK-994, an oral orexin agonist in clinical development for the treatment of narcolepsy type 1 (NT1), Breakthrough Therapy status. Press release. Takeda Pharmaceutical Company Limited. Accessed July 28, 2021.gshttps: //www.businesswire.com/news/home/20210728005256/en/US-Food-and-Drug-Administration-Grants-Breakthrough-Therapy-Designation-to-Takeda%E2%80 % 99s-Investigational-Compound-TAK-994-an-oral-orexin-agonist-in-clinical-development-for-narcolepsy-type-1-NT1.
This article originally appeared on MPR
Subjects:
Sleep disorders in narcolepsy
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