On July 28, 2021, Takeda Pharmaceutical Company announced the FDA granted Breakthrough Therapy designation to TAK-994, which may provide a future treatment option targeting the orexin deficiency underlying narcolepsy type 1.
About TAK-994
TAK-994 is a Phase 2 investigational oral orexin agonist designed to selectively target orexin 2 receptors. The drug is currently being studied for the treatment of excessive daytime sleepiness in patients with narcolepsy type 1. If approved, the drug may target the underlying orexin deficiency that is central to the sleep disorder.
According to Takeda, the FDA designation is based on early phase and preliminary clinical data that indicates TAK-994 may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in patients with narcolepsy type 1.
The FDA’s Breakthrough Therapy designation is “a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”
Currently, the drug is being studied in an ongoing Phase 2 study.
About narcolepsy
Narcolepsy, a lifelong neurological disorder, disrupts normal sleep-wake cycles, causing patients to feel overwhelmingly tired or experience sudden episodes of muscle weakness known as cataplexy. With a prevalence of about one in 2,000 people, this often-undiagnosed condition can significantly impact daily activities, such as eating, walking and driving, highlighting the importance of recognizing and managing its symptoms.
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