Takeda plans to initiate global Phase 3 trials of TAK-861 in NT1 in the first half of its fiscal year 2024. The Phase 2b data also supported the recent Breakthrough Therapy designation for TAK-861 for the treatment of EDS in NT1 from the US Food and Drug Administration (FDA). Breakthrough Therapy designation is a process designed to expedite the development and review of a drug that is intended to treat a serious or life-threatening condition, for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.
Takeda will be hosting a call to discuss these data this evening, June 3, at 7:30 pm CT for investors and analysts. Presentation slides and a virtual meeting link will be available here.
Additional presentations on TAK-861 will be shared during the SLEEP 2024 poster presentation session on Tuesday, June 4 , from 10:00 to 11:45 am CT, assessing function and health-related quality of life in individuals with NT1, as well as patient satisfaction with TAK-861 treatment.
There is no change in Takeda's full year consolidated forecast for the fiscal year ending March 31, 2025 (FY2024), announced on May 9, 2024.
About Takeda's Orexin Franchise
Takeda is advancing the field of orexin therapeutics with a china phone number data multi-asset franchise offering tailored treatments to unlock the full potential of orexin. Orexin is a key regulator of the sleep-wake cycle and is involved in other essential functions, including respiration and metabolism. TAK-861 is the leading program in this franchise. The company is also progressing multiple orexin agonists in patient populations with normal levels of orexin neuropeptides and other indications where orexin biology is implicated. This includes TAK-360, an oral OX2R agonist being investigated for narcolepsy type 2 and idiopathic hypersomnia, which recently initiated a Phase 1 trial and received Fast Track designation from the US FDA, and danavorexton (TAK-925), an intravenously administered OX2R agonist being investigated in a Phase 2 trial in patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners , we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit.