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Jazz Disputes FDA’s Approval Of Lumryz Over Xywav’s Orphan Exclusivity, Citing Lack Of Comparative Study

 
• By Brenda Sandburg

Lawsuit argues FDA wrongly determined that Avadel’s Lumryz is ‘clinically superior’ to Xywav because of once-nightly dosing. FDA’s Division of Neurology revised its initial opinion based on views of CDHR’s sleep team and additional input from the agency’s orphan drug office.

Narcolepsy
Jazz Pharmaceuticals sues FDA over its approval of a competing narcolepsy drug • Source: Shutterstock

The US Food and Drug Administration is once again embroiled in litigation over its interpretation of the Orphan Drug Act as Jazz Pharmaceuticals plc is challenging the agency’s conclusion that Avadel Pharmaceuticals plc’s narcolepsy drug Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (calcium, magnesium, potassium and sodium oxybates) due to its once-nightly dosing.

In a 22 June complaint against the agency, Jazz contends that FDA does not have the authority to use a clinical superiority finding to overcome Xywav’s orphan drug exclusivity,...

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