By Alyx Arnett
In the filing in the United States District Court for the District of Columbia, Jazz alleges that, despite the orphan drug exclusivity protecting Jazz’s low-sodium oxybate product Xywav for seven years, the FDA approved Avadel Pharmaceuticals plc’s new drug application (NDA) and granted Lumryz orphan drug exclusivity too. This was based on the FDA’s finding that Lumryz makes a major contribution to patient care and is therefore clinically superior to Xywav and Xyrem.
Jazz argues that, since there has been no head-to-head comparative trial conducted to assess the efficacy or safety of Lumryz as compared to Xywav, the FDA’s determination is inconsistent with FDA regulations requiring claims of greater efficacy to be supported by substantial evidence. Jazz argues that the FDA acted without lawful basis when it determined that the once-nightly dosing regimen for Lumryz makes a major contribution to patient care by providing convenience and an additional medical benefit for narcolepsy patients by allowing them to achieve normal sleep architecture.
Responding to the allegations, a spokesperson for Avadel, the marketer of Lumryz, tells Sleep Review that the FDA’s decisions were both lawful and factually grounded.
“Avadel intends to vigorously defend FDA’s decisions to approve and award orphan drug exclusivity for Lumryz, which were entirely proper under the law and rooted in the facts. Lumryz, approved by FDA on May 1, 2023, provides once-nightly dosing enabling people with narcolepsy to avoid awakening in the middle of the night to take a second dose of a first-generation oxybate product,” according to the company spokesperson.
Jazz is asking the court to vacate and set aside its approval of the Lumryz NDA and seeks a declaration that it was “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law.”