The Zhitong Finance App learned that on August 5, local time, the FDA announced that Takeda (TAK.US) Oveporexton (Oveporexton) tablets (Oveporexton) have been approved for marketing by the US FDA to treat narcolepsy type 1 (NT1). Previously, the product was granted breakthrough therapy status and priority review by the FDA. In July of this year, Opreton was approved for listing in China.
According to the press release, this is the first drug approved to treat narcolepsy type 1. It can relieve all symptoms of the disease, and it is also the first drug to work by directly targeting the loss of the orexin signaling pathway that causes the disease.
Narcolepsy is a rare chronic neurological disorder in which it is difficult to maintain sleep and wakefulness. The main clinical features are excessive daytime sleepiness (EDS), cataplexy, and other rapid eye movement (REM) sleep phenomena (such as sleep paralysis and sleep hallucinations) that are difficult to control. Type 1 narcolepsy, also known as cataplexy narcolepsy, is due to a significant loss of orexinergic neurons in the lateral hypothalamus region of the hypothalamus, and the clinical symptoms are characterized by excessive sleepiness during the day accompanied by sudden bouts of sudden bouts of restlessness.
Opreton (TAK-861, formerly known as obolatone) is an oral orexin receptor 2 (OX2R) selective agonist. It can selectively stimulate OX2R to restore downstream neurotransmitter activity lost when endogenous orexin levels decline, and address the underlying lack of orexin that causes narcolepsy type 1.