Jazz's reworked narcolepsy drug wins 7 years of orphan exclusivity thanks to rare 'clinical superiority' finding from FDA
Jazz Pharmaceuticals successfully redesigned its blockbuster narcolepsy drug Xyrem to make it safer by greatly reducing its sodium content. That tweak was enough for Jazz to win 7 years of orphan drug exclusivity for that redesigned followup — marketed as Xywav — as part of an infrequently used FDA program that evaluates drugs on the basis of demonstrating clinical superiority.
“The differences in the sodium content of the two products at the recommended doses will be clinically meaningful in reducing cardiovascular morbidity in a substantial proportion of patients for whom the drug is indicated,” FDA said in making its designation for Xywav. The agency has declared such “clinical superiority” findings just eight other times since August 2017 and is allowed to do so thanks to the FDA Reauthorization Act of 2017.
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