The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TAK-994 for the treatment of excessive daytime sleepiness in patients with narcolepsy type 1.

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 narcolepsy type 1 or type 2 in a phase 2 study (ClinicalTrials.gov Identifier: NCT04096560). Data from the completed study will be presented at a future scientific conference.

“Individuals with narcolepsy type 1 suffer from excessive daytime sleepiness, which might mean routinely falling asleep at work or in school,” said Sarah Sheikh, Head, Neuroscience Therapeutic Area Unit at Takeda. “If approved, investigational TAK-994 has the potential to transform the way we currently treat [narcolepsy type 1] by addressing the underlying orexin deficiency central to the disease.”

The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to therapies that are expected to have an impact on factors such as survival and daily functioning.


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Reference

US Food and Drug Administration grants Breakthrough Therapy designation to Takeda’s investigational compound, TAK-994, an oral orexin agonist in clinical development for narcolepsy type 1 (NT1). News release. Takeda Pharmaceutical Company Limited. Accessed July 28, 2021.gshttps://www.businesswire.com/news/home/20210728005256/en/U.S.-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