Jazz Pharmaceuticals Sues FDA Over Approval Of Rival Product, Calls It 'Unlawful'

Jazz Pharmaceuticals plc JAZZ has filed suit against the FDA for approving Avadel Pharmaceuticals Plc's AVDL Lumryz (sodium oxybate extended-release) for cataplexy or excessive daytime sleepiness in adult patients with narcolepsy.

Jazz says Avadel's Lumryz is an extended-release reformulation of its high sodium oxybate product Xyrem for narcolepsy.

Jazz argues that the approval was unlawful and violates the orphan drug exclusivity of Xywav.

In an SEC filing, Jazz alleges that FDA acted outside its authority under the Orphan Drug Act when, despite the orphan drug exclusivity (ODE) protecting Jazz's low-sodium oxybate product Xywav, FDA approved the Lumryz and granted Lumryz ODE based on FDA's finding that Lumryz makes a major contribution to patient care and is therefore clinically superior to Xywav and Xyrem. 

In July 2022, the FDA tentatively approved Lumryz for cataplexy or EDS in adults with narcolepsy, and in May, the FDA granted final approval to Lumryz.

In March, a federal appeals court rejected Jazz Pharmaceuticals' attempt to overturn a lower court ruling invalidating a patent claim covering the company's Risk Evaluation and Mitigation Strategies distribution system for Xyrem.

Price Action: JAZZ shares closed at $127.78 on Thursday, and AVDL shares are down 5.77% at $14.37 during the premarket session on the last check Friday.