Jazz Pharmaceuticals sues, asks court to set aside FDA’s approval of Lumryz

In a regulatory filing, Jazz Pharmaceuticals disclosed that a subsidiary of the company filed a complaint in the United States District Court for the District of Columbia seeking a declaration that the U.S. Food and Drug Administration’s approval on May 1, 2023 of the New Drug Application, or “NDA,” for Lumryz, an extended-release reformulation of Jazz’s high sodium oxybate product Xyrem, for the treatment of cataplexy or excessive daytime sleepiness, or “EDS,” in adult patients with narcolepsy, was unlawful. The filing stated: “Jazz is committed to protecting the work it has done to bring life-changing medicines to patients, which makes it possible for Jazz to research, develop, and provide therapies for patients living with serious, debilitating disorders. The Orphan Drug Act is critical to ensuring the ongoing development of products to treat rare diseases, and the company believes undercutting the statutory intent of the Orphan Drug Act, as the company alleges FDA has done in this case, has a direct impact on patients’ needs and compromises patient safety… Jazz Inc.’s complaint, filed pursuant to the Administrative Procedure Act, seeks to have the Court vacate and set aside FDA’s approval of the Lumryz NDA and seeks a declaration that FDA’s approval of the Lumryz NDA was arbitrary, capricious, an abuse of discretion and otherwise not in accordance with law; and that approval of the Lumryz NDA was in excess of FDA’s statutory authority and was made without observance of procedure required by law. Jazz cannot predict the timing or ultimate outcome of this litigation or the impact of this litigation on its oxybate business.”