FDA Breakthrough status for Takeda's investigational drug TAK-994 for EDS

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) says that the US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) to TAK-994, its Phase II investiga00tional oral orexin agonist, which is designed to selectively target orexin 2 receptors.

TAK-994 is currently being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1), a chronic neurological disorder that alters the sleep-wake cycle. EDS is a hallmark symptom of NT1 and is characterized by a person’s inability to stay awake and alert throughout the day, and falling asleep unintentionally or at inappropriate times on a daily basis.

The FDA’s Breakthrough Therapy designation process is designed to expedite the development and review of a drug that is intended to treat a serious condition, for which preliminary clinical evidence exists indicating it may demonstrate a substantial improvement over available therapies on at least one clinically significant endpoint.