Vanda's Hetlioz (tasimelteon) Receives the US FDA's Approval for Nighttime Sleep Disturbances in Smith-Magenis Syndrome
Shots:
- The approval is based on study assessing Heltioz vs PBO in both adults with SMS taking the capsule formulation and children with SMS taking the liquid formulation. The safety profile of the therapy is in consistent with previous study conducted for the treatment of Non-24-Hour Sleep-Wake Disorder
- Hetlioz capsules will available imminently for adults and Hetlioz LQ liquid formulation for children is expected to be available in Q1’21
- Hetlioz is melatonin receptor agonist & is an approved therapy in the US & EU
Ref: PRNewswire | Image: Vanda Pharma
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