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Harmony Biosciences' Wakix (pitolisant) Receives the US FDA's Approval for Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy

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Harmony Biosciences' Wakix (pitolisant) Receives the US FDA's Approval for Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy

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  • The US FDA approval is based on HARMONY 1 and HARMONY 1b clinical study results assessing Wakix (pitolisant) vs PBO or active control in 261 narcolepsy patients
  • The study resulted in significant improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) score  
  • Wakix (pitolisant) is a selective histamine3 (H₃) receptor antagonist/inverse agonist will be available in Q4’19 and has also received Orphan Drug Designation for the treatment of narcolepsy in 2010. In 2017- Harmony in-licensed Pitolisant from Bioprojet Pharma

Click here to­ read full press release/ article | Ref: PRNewswire | Image: IOL


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