Takeda receives P3T approval for TAK-861 in Korea

its narcolepsy drug

MFDS approves the clinical trial on the 20th...will evaluate the safety and efficacy of the drug in treating Type 1 narcolepsy

The Japanese pharmaceutical company Takeda Pharmaceuticals will enter Phase III clinical trials for TAK-861, its new drug candidate for narcolepsy, in Korea.

 

On the 20th, the Ministry of Food and Drug Safety (MFDS) on Tuesday approved a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of TAK-861 for the treatment of narcolepsy with cataplexy (narcolepsy type 1).

 

The Phase III trial will be conducted at Seoul National University Hospital, St.

 

Vincent's Hospital, and Keimyung University Dongsan Medical Center.

 

Narcolepsy is a neurological disorder and sleep disorder characterized by episodic drowsiness during daily life.

 

Narcolepsy is categorized into two types: Type 1 narcolepsy, which is characterized by cataplexy or a cerebrospinal fluid hypocretin level of 110 pg/mL or less; and Type 2 narcolepsy, which is characterized by a hypocretin level of 110 pg/mL or higher without cataplexy or no measure.

 

TAK-861 is being developed for the treatment of patients with Type 1 narcolepsy, as stimulation of orexin receptor 2 in patients with Type 1 narcolepsy may restore orexin signaling by targeting the underlying pathophysiology of the disease.

 

According to data presented by Takeda at SLEEP 2024 in June, which outlined the results of the company’s clinical trial evaluating 112 patients with type 1 narcolepsy, TAK-861 demonstrated statistically significant and clinically meaningful improvements compared to placebo in objective and subjective measures of wakefulness, including the primary endpoint, the Maintenance of Wakefulness Test (MWT) at week 8.

 

Consistent statistically significant and clinically meaningful improvements were also observed in secondary endpoints, including the Epworth Sleepiness Scale (ESS) and Weekly Cataplexy Rate (WCR), Products available in the domestic narcolepsy treatment market include JW Pharmaceuticals' Provigil, Hanmi Pharmaceutical's Modanil, and Handok Teva's Nuvigil, all of which contain modafinil.

 

Mitsubishi Tandabe’s Wakix is a pitolisant hydrochloride drug used for narcolepsy in adults with or without cataplexy.

 

Wakix is the only product approved in Korea for the treatment of narcolepsy with cataplexy, which is defined as a sudden loss of muscle tone provoked by strong emotion.