Summary: A US court upheld the FDA’s approval of Avadel Pharmaceuticals’ Lumryz, a once-nightly oxybate for narcolepsy, rejecting Jazz Pharmaceuticals’ challenge on orphan status and clinical superiority grounds. The ruling confirms Lumryz’s orphan drug exclusivity based on its clinical advantages over Jazz’s twice-nightly oxybate.
Key Takeaways:
- Court Upholds FDA Approval: The US court ruled in favor of the FDA, dismissing Jazz’s challenge to Lumryz’s approval.
- Orphan Drug Exclusivity Retained: Lumryz retains its orphan drug status based on its unique once-nightly dosing for narcolepsy.
- Clinical Superiority Recognized: Lumryz was deemed clinically superior to existing treatments, supporting its FDA approval and market position.
Avadel Pharmaceuticals plc announced that the US District Court for the District of Columbia ruled in favor of the US Food and Drug Administration (FDA) in a suit brought by Jazz Pharmaceuticals Inc under the Administrative Procedure Act regarding the FDA’s approval of Lumryz, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy.
With this ruling, the approval of Lumryz is upheld based on the FDA’s determination that Lumryz is clinically superior to Jazz’s twice-nightly oxybate products.
Following the FDA’s final approval and grant of Orphan Drug Exclusivity to Lumryz in May 2023, Jazz filed a complaint against the FDA claiming that Lumryz’s approval was not in alignment with the Orphan Drug Act. Avadel Pharmaceuticals intervened to defend the FDA’s actions and successfully argued to uphold the approval of Lumryz.
“We are pleased with the court’s ruling in favor of the FDA’s clinical superiority determination for Lumryz in conjunction with final approval for use in adults with narcolepsy. With the court’s decision, Lumryz will continue to be available to the narcolepsy community and retain its Orphan Drug Exclusivity,” says Greg Divis, chief executive officer at Avadel Pharmaceuticals, in a news release. “Yesterday’s ruling further solidifies Lumryz’s unique once-at-bedtime dosing schedule as a major contribution to patient care and enables us to continue executing on our commercial launch and expanding Lumryz’s reach within the narcolepsy community.”
Lumryz’s Approval
Lumryz was approved by the FDA on May 1, 2023, as a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. On Oct 16, 2024, Lumryz was additionally approved as a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy.
The FDA approval of Lumryz was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal phase 3 trial in adults with narcolepsy. Lumryz demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: excessive daytime sleepiness, clinicians’ overall assessment of patients’ functioning, and cataplexy attacks, for all three evaluated doses when compared to placebo.
With its original approval in May 2023, the FDA granted seven years of Orphan Drug Exclusivity to Lumryz for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy due to a finding of clinical superiority of Lumryz relative to currently available oxybate treatments.
Similarly, with its pediatric approval in October 2024, the FDA granted another seven years of Orphan Drug Exclusivity to Lumryz for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy due to a finding of clinical superiority of Lumryz relative to currently available oxybate treatments.
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