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

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

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

Shots:

  • 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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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