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

  | Ref: Jazz Pharma | Image: Jazz Pharma