RareStone Inc. Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China
Application is supported by data used in the Wakix® European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) approvals
BOSTON and SHANGHAI, July 21, 2021 /PRNewswire/ -- RareStone Inc., formerly Citrine Medicine, a China-based rare disease therapeutics company, today announced its submission of a New Drug Application (NDA) for Wakix® (pitolisant). Wakix® will be considered for approval in the treatment of narcolepsy with and without cataplexy in Greater China.
"We are very excited that the NDA for Wakix® has been submitted to National Medical Products Association in China," said Melissa Bradford-Klug, President and Chief Business Officer of RareStone Inc. "This action brings RareStone one step closer to being able to introduce much-needed, clinically-validated rare disease drugs to China." Through a partnership announced in Q4 2020 with Bioprojet, RareStone has exclusive rights for the commercialization and development of Wakix® in China.
Wakix® is a selective histamine H3-receptor antagonist/inverse agonist that enhances the activity of histaminergic neurons and increases the release of the brain chemical histamine to increase a patient's wakefulness and alertness. It is approved by the EMA and the U.S. FDA to treat adults suffering from narcolepsy, a serious, chronic disorder characterized by excessive daytime sleepiness (EDS), with or without cataplexy.
About RareStone Inc.
RareStone Inc., formerly Citrine Medicine, is dedicated to improving the lives of patients with rare and intractable diseases by making diagnosis and essential treatments available and accessible to those who need them in China. Our mission is to build the first rare disease ecosystem in China, and in doing so, enable people with rare diseases to live more normal lives. RareStone's lead product candidate, Wakix® (pitolisant), is an investigational oral drug in development for the treatment of narcolepsy and obstructive sleep apnea in China. RareStone Group is headquartered in Shanghai and has other offices in Beijing, China and Cambridge, Mass.
For more information, visit www.rarestonegroup.com.
About Pitolisant
Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist which enhances the activity of histaminergic neurons. The drug was approved by the EMA in 2016 for the treatment of narcolepsy in adults with or without cataplexy and is marketed in major countries in Europe and was approved by the FDA in 2018. Pitolisant has an orphan designation in the EU and the US for the treatment of narcolepsy.
RareStone Inc. Media Contact:
Melissa Bradford-Klug
President and Chief Business Officer, RareStone Inc.
[email protected]
SOURCE RareStone Inc.
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