The first in a new, potentially lucrative class of sleep medicines is now headed for market, with the Food and Drug Administration approving it on Wednesday as a treatment for the less common form of narcolepsy.
Developed by Japan-based Takeda Pharmaceutical, the medicine amplifies “orexin-2,” a protein that regulates key body functions like appetite, arousal and alertness. A pair of large clinical trials showed it was significantly better than a placebo at keeping patients awake as well as curbing the sudden muscle weakness that’s a trademark of “Type 1” narcolepsy. It was also generally well-tolerated by patients.
Takeda will sell the medicine under the brand name Orzeyful. While the company didn’t disclose the drug’s price, analysts at Jefferies guessed Orzeyful could cost anywhere from $142,000 per patient per year — on par with another sleep medication called Xywav — to north of $250,000. At the lower end of that range, analyst Stephen Barker predicts net annual sales of Orzeyful will peak at roughly $2 billion.
"For those of us living with narcolepsy type 1, symptoms reshape everyday life and extend far beyond what most people understand about the condition," said Julie Flygare, CEO of the patient advocacy group Project Sleep, in a statement from Takeda. As such, Orzeyful’s approval “is a historic moment that expands our treatment choices and gives me great hope for the future.”
