Jazz Receives FDA Approval for Xyrem’s (sodium oxybate) sNDA to Treat Cataplexy or Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

 Jazz Receives FDA Approval for Xyrem’s (sodium oxybate) sNDA to Treat Cataplexy or Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

Jazz Receives FDA Approval for Xyrem’s (sodium oxybate) sNDA to Treat Cataplexy or Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy

Shots:

  • The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs.
  • P-II/III EXPRESS study results: @2 wks. change in weekly number of cataplexy attacks, change in EDS; @47 wks. increment in weekly cataplexy attacks (0.3 vs 12.7); no new safety signals observed published in the Lancet Child & Adolescent Health 2018
  • to Micromedex DRUGDEX monograph, Xyrem (CIIA) is recommended for cataplexy in narcolepsy in the pediatric patient and also a novel FDA approved PO (CIII) drug for pediatric patients (7 yrs) & adults indicated for cataplexy and excessive daytime sleepiness in narcolepsy

Click here to read full press release/ article | Ref: Jazz Pharmaceuticals | Image: Stock Market Daily

Shiwani Sharma

Shiwani Sharma was Senior Editor 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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