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Drug Discovery and Development

FDA grants breakthrough therapy designation to Takeda narcolepsy drug candidate

The drug would be a novel treatment for narcolepsy type 1, if approved.

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TakedaTakeda (NYSE:TAK) has won breakthrough therapy designation from FDA for TAK-994, an experimental oral orexin agonist. Now in a Phase 2 trial, TAK-994 is formulated to selectively target orexin 2 receptors. Orexin is a neuropeptide that supports normal wakefulness. Orexin deficiency is associated with narcolepsy.

Takeda is testing the potential of TAK-994 to treat excessive daytime sleepiness in people with narcolepsy type 1 (NT1), which involves a disturbance of sleep-wake cycles and the presence of cataplexy. Cataplex itself involves a sudden muscle weakness occurring when a person is awake.

Currently, the majority of therapies for NT1 are repurposed, including a range of stimulants and antidepressants. In addition, FDA has indicated sodium oxybate (Xyrem) for cataplexy in narcolepsy and excessive daytime sleepiness, which is effective but has a risk of respiratory depression and has significant potential for abuse.

Following the announcement, Takeda shares ticked up 2.39%, or $0.40, to $17.17, in mid-afternoon trading.

Filed Under: clinical trials, Drug Discovery, Neurological Disease

 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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