Jazz’ Xywav Receives the US FDA’s Approval for the Treatment of Idiopathic Hypersomnia

August 13, 2021 Auto Bot approval, FDA, Jazz, regulatory 0

Shots:

  • The approval is based on the P-III withdrawal study that evaluates the efficacy and safety of Xywav (twice or once-nightly regimen, oral solution) vs PBO in adults with IH. The therapy is expected to be available in late 2021, following REMS implementation
  • The results demonstrated the change in the 1EPs of ESS score & 2EPs of PGIc and IHSS
  • In Sept’20, the therapy received FTD from the FDA for IH & PR designation as part of sNDA acceptance in Apr’21. Additionally, a Nurse Case management program is available to support the patient with Xywav treatment & JazzCares patient assistance program will offer free or low-cost drugs to patients without insurance or insurance coverage

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