AVADEL PHARMACEUTICALS PUBLIC LIMITED COMPANY

Court Upholds FDA's Approval of Avadel's Lumryz Over Jazz's Xywav in Orphan Drug Exclusivity Dispute

- A U.S. District Court upheld the FDA's decision to approve Avadel's Lumryz, a once-nightly sodium oxybate formulation, for narcolepsy. - The court agreed with the FDA that Lumryz is clinically superior to Jazz Pharmaceuticals' Xywav, which requires twice-nightly dosing, due to its less disruptive effect on sleep. - The ruling affirms the FDA's authority to approve a subsequent orphan drug during the exclusivity period of an existing one if the new drug demonstrates clinical superiority. - The court rejected Jazz's claims that the FDA acted arbitrarily by not requiring 'comparable safety' and by deviating from internal dispute resolution policies.