Appeals Court Upholds FDA Approval Of Avadel's LUMRYZ In Narcolepsy In Administrative Procedure Act Litigation

Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for the District of Columbia Circuit (the "Appeals Court") affirmed a prior decision of the U.S. District Court for the District of Columbia (the "District Court") in favor of the U.S. Food and Drug Administration ("FDA") in a suit brought by Jazz Pharmaceuticals Inc. ("Jazz") regarding the FDA's approval of LUMRYZTM, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.

Following the District Court's ruling in favor of the FDA and Avadel in October 2024, which granted the FDA's Motions for Summary Judgment with respect to Jazz's complaint and denied Jazz's Motion for Summary Judgment, Jazz filed a notice of appeal to the Appeals Court. On June 27, 2025, the Appeals Court, in a unanimous panel decision, affirmed the District Court's ruling and upheld the FDA's approval of LUMRYZ.