Takeda launches Orzeyful in the US for adults with narcolepsy type 1
The orexin-targeting tablet is now available through a specialty pharmacy, following the FDA's Aug. 5 approval.
Adrian Kessler
U.S. prescriptions for the orexin-targeting narcolepsy medicine Orzeyful can now begin as Takeda Pharmaceutical Company Limited TYO4502 NYSETAK announced its availability on Thursday. The launch opens a new U.S. revenue stream for the medicine, approved for adults with narcolepsy type 1.
Takeda's U.S. product site, checked Nov. 12, confirms availability and describes access through a specialty pharmacy. Its patient-support program offers insurance reviews and financial assistance for eligible patients, with commercial insurance among the conditions for its quick-start and co-pay programs. Takeda has scheduled a capital markets day for Dec. 11.
Takeda is a large Japanese drugmaker with global commercial operations spanning neuroscience, rare diseases, oncology and other therapeutic areas.
Takeda's U.S. depositary shares closed at US$20.84 in New York on Nov. 11 at 4:00 p.m. EST, according to the NYSETAK page on Google Finance. That close preceded Thursday's announcement and does not establish a launch reaction.
The FDA approved Orzeyful on Aug. 5 for adults with narcolepsy type 1, a condition driven by loss of orexin signalling in the brain. Oveporexton activates the receptor normally stimulated by orexin, which helps regulate wakefulness, sleep and muscle tone. The disease can also cause sleep paralysis, hallucinations around sleep and disrupted nighttime sleep, according to the FDA.
The FDA describes the medicine as an oral tablet taken twice daily. Its notice says safety and effectiveness have not been established in patients younger than 18, so the adult indication does not establish a pediatric treatment option.
"This new drug is the first medicine that impacts the underlying biology of the disease, treating narcolepsy type 1 as a whole," Tiffany R. Farchione, director of the FDA's psychiatry division, said in the approval notice.
The agency evaluated two randomized, double-blind, placebo-controlled studies enrolling 273 adults over 12 weeks. It reported improved daytime wakefulness with the 2-milligram dose against placebo, alongside improvements in sleepiness and cataplexy, the sudden loss of muscle tone.
The notice does not provide numerical treatment differences or p values. The FDA listed insomnia, increased urinary frequency, urinary urgency and increased saliva production as common side effects, and said the medicine should not be used with strong CYP3A inhibitors.
Launch Extends An Overseas Rollout
For a listed-company comparison, Jazz Pharmaceuticals plc NASDAQJAZZ highlighted Xywav in its Nov. 2 quarterly results. Jazz reported record quarterly group revenue of US$1.2 billion, up 10 per cent from a year earlier.
Those are portfolio-wide revenues, rather than a measure of the narcolepsy type 1 market. Jazz shares closed at US$248.24 on Nov. 11 at 4:00 p.m. EST in New York, according to the NASDAQJAZZ page on Google Finance.
Takeda's product page does not state a list price or sales forecast for the U.S. launch. The new availability extends a commercial rollout already under way overseas. Its Oct. 29 first-half results said Orzeyful was available in Japan and China, while U.S. availability still depended on Drug Enforcement Administration scheduling at that date.
Read more: Takeda launches Orzeyful in Japan and China for narcolepsy type 1
The same results positioned Orzeyful alongside Mimrylo and zasocitinib in Takeda's near-term commercial priorities. Mimrylo launched in the United States in August, while the FDA accepted the zasocitinib application for priority review.
Read more: Takeda details 36.5 per cent complete clearance versus Sotyktu in Phase 3
Takeda's next dated investor event identified in those results is its Dec. 11 capital markets day in Tokyo. Management said it would use that event to explain its growth strategy and plans to build leadership in its core therapeutic areas.
