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Narcolepsy (Image source: neurologist-ahmedabad.
com)
com)
News on July 22, 2021 // --RareStone Group recently announced that it has submitted a new drug listing application (NDA) for Wakix® (pitolisant ) to the National Medical Products Administration (NMPA) for the treatment of patients with or without Falling narcolepsy
.
Wakix® is expected to become the first therapeutic drug approved for the treatment of narcolepsy in China
.
Wakix® (pitolisant, Tilolisant) is used for the treatment of narcolepsy with or without cataplexy.
Wakix® is expected to become the first therapeutic drug approved for the treatment of narcolepsy in China
.
Wakix® has been approved for marketing in the European Union and the United States for the treatment of adult narcolepsy
.
In terms of medication, the drug is administered orally, once every morning when you wake up
.
Wakix® has been approved for marketing in the EU and the U..
In terms of medication, the drug is administered orally, once every morning when you wake up
.
S.
Narcolepsy is one of the rare diseases recognized globally.
It is a serious chronic disease characterized by excessive daytime sleepiness (EDS), with or without cataplexy
.
At present, there are more than 700,000 narcolepsy patients in China , and no drugs have been approved for the treatment of narcolepsy .
Doctors have very limited options in the treatment of narcolepsy.
Many patients have been plagued by the disease.
There is a huge unmet medical need for the treatment of the disease
.
There are more than 700,000 narcolepsy patients in China that have yet to have drugs approved for the treatment of narcolepsyIt is a serious chronic disease characterized by excessive daytime sleepiness (EDS), with or without cataplexy
.
At present, there are more than 700,000 narcolepsy patients in China , and no drugs have been approved for the treatment of narcolepsy .
Doctors have very limited options in the treatment of narcolepsy.
Many patients have been plagued by the disease.
There is a huge unmet medical need for the treatment of the disease
.
Melissa Bradford-Klug, Chief Commercial Officer of Langyu Group and President of Langhua Pharmaceutical America, said: "We are very pleased that Wakix®'s New Drug Application (NDA) has been submitted to NMPA
.
This action has distanced Langyu Group.
The introduction of much-needed products is one step closer.
Through the partnership announced with Bioprojet in the fourth quarter of 2020, Langyu Group has obtained the exclusive right to commercialize and develop Wakix® in China
.
"
.
This action has distanced Langyu Group.
The introduction of much-needed products is one step closer.
Through the partnership announced with Bioprojet in the fourth quarter of 2020, Langyu Group has obtained the exclusive right to commercialize and develop Wakix® in China
.
"
Narcolepsy (narcolepsy) is a chronic, severe, and unstable sleep-wake state neurological disorder.
It is also a rare disease, with an incidence of about 25-50 people per 100,000 population.
.
The disease mainly occurs in adolescents and young people, usually onset at 5 years old, most of which are 10-25 years old
.
Narcolepsy is mainly manifested as drowsiness, cataplexy and night sleep disturbances, such as hallucinations before going to bed and sleep paralysis, which can cause serious harm to patients
.
Narcolepsy also brings a huge personal and socioeconomic burden, usually manifested in education and employment problems, such as poor academic performance, absenteeism and unemployment, as well as damage to interpersonal relationships and mental health
.
It is also a rare disease, with an incidence of about 25-50 people per 100,000 population.
.
The disease mainly occurs in adolescents and young people, usually onset at 5 years old, most of which are 10-25 years old
.
Narcolepsy is mainly manifested as drowsiness, cataplexy and night sleep disturbances, such as hallucinations before going to bed and sleep paralysis, which can cause serious harm to patients
.
Narcolepsy also brings a huge personal and socioeconomic burden, usually manifested in education and employment problems, such as poor academic performance, absenteeism and unemployment, as well as damage to interpersonal relationships and mental health
.
The active ingredient of Wakix® is pitolisant, which is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which increases the nerves that promote wakefulness in the brain by enhancing the activity of histaminergic neurons The synthesis and release of the transmitter histamine improves the patient's wakefulness and alertness
.
Pitolisant, which is a selective histamine 3 (H3) receptor antagonist/inverse agonist, increases the synthesis of histamine, the neurotransmitter that promotes wakefulness in the brain by enhancing the activity of histaminergic neurons And release, improve the patient's sobriety and alertness .
.
Wakix® received marketing approval in the European Union and the United States in March 2016 and August 2019 for the treatment of narcolepsy with or without cataplexy, and was recognized by the US FDA as a breakthrough in narcolepsy in 2020 Sex therapy drugs
.
Wakix® was developed by the French company Bioprojet.
Langhua Pharmaceutical, a subsidiary of Langyu Group, officially signed a contract with Bioprojet at the end of 2020 to obtain commercialization rights in the Chinese market
.
2020 by the US FDA found sleeping disease is episodic breakthrough drugs FDA.
Wakix® was developed by the French company Bioprojet.
Langhua Pharmaceutical, a subsidiary of Langyu Group, officially signed a contract with Bioprojet at the end of 2020 to obtain commercialization rights in the Chinese market
.
According to an announcement issued by Langyu Group, on May 7 this year, Wakix® issued the first domestic prescription at the Hainan Boao Yiling Life Quality Improvement Center
.
Thanks to the policy dividends of the Boao Lecheng Pioneer Zone, this breakthrough drug for the treatment of narcolepsy has completed the first clinical application in China, bringing the latest treatment plan synchronized with the world's advanced level for patients with narcolepsy in China
.
()
.
Thanks to the policy dividends of the Boao Lecheng Pioneer Zone, this breakthrough drug for the treatment of narcolepsy has completed the first clinical application in China, bringing the latest treatment plan synchronized with the world's advanced level for patients with narcolepsy in China
.
()
Original source: RareStone Inc.
Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China
RareStone Inc. Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China
Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China
