万达称法院裁决为赫特利奥斯时差迹象打开了大门

2025-08-18 21:02

A federal appellate court decision could provide a path for Vanda Pharmaceuticals to finally win approval of an sNDA it has been seeking since 2018 for Hetlioz (tasimelteon) for an additional indication for jet lag.
The pharma had initially sued the U.S. FDA in a federal court for delaying a request for a hearing regarding the application. The agency never granted that hearing and instead issued summary judgment denying the application. Vanda then brought the matter to an appellate court.
The U.S. Court of Appeals for the D.C. Circuit ruled that expert analysis provided by the drugmaker was "specific, reasoned, and rooted in evidence," the FDA's "treatment of Vanda's evidence is cursory," and Vanda "clearly offered meaningful evidence of tasimelteon's efficacy in improving sleep disturbance."
The case has been remanded back to the FDA which can take one of two actions: Approve the sNDA or grant a hearing.

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