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RareStone Inc. Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China | ||
By: PR Newswire Association LLC. - 21 Jul 2021 | Back to overview list |
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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. For more information, visit www.rarestonegroup.com. About Pitolisant RareStone Inc. Media Contact: View original content to download multimedia:https://www.prnewswire.com/news-releases/rarestone-inc-announces-submission-of-new-drug-application-nda-of-wakix-pitolisant-for-narcolepsy-with-and-without-cataplexy-in-china-301337923.html SOURCE RareStone Inc. |
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