RareStone Inc. Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China
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.
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SOURCE RareStone Inc.