Avadel Pharmaceuticals to Intervene in Jazz Pharmaceuticals Lawsuit Over FDA Ruling

By Denny Jacob

Avadel Pharmaceuticals intends to intervene in a lawsuit filed by Jazz Pharmaceuticals against the U.S. Food and Drug Administration, Avadel Chief Executive Greg Divis said.

Ireland-based biopharmaceutical company Jazz Pharmaceuticals said Thursday in a regulatory filing that its lawsuit alleges that the FDA acted outside its authority under the Orphan Drug Act when it approved Avadel's new drug application for Lumryz and granted it orphan drug exclusivity.

The lawsuit alleges the FDA acted without lawful basis when the agency determined that Lumryz boosted patient care and was purportedly clinically superior to two similar drugs that Jazz Pharmaceutical produces, Xywav and Xyrem.

Divis said that Avadel would "vigorously defend FDA's decisions to approve Lumryz and grant it orphan drug exclusivity, which were entirely proper under the law and rooted in the facts." He added that Lumryz launched earlier this month and is on track with expectations.

Jazz Pharmaceuticals said Xywav already had orphan drug exclusivity and described Lumryz as an extended-release reformulation of Xyrem. The drugs treat cataplexy, or excessive daytime sleepiness, in adults with narcolepsy.

Write to Denny Jacob at [e-mail]

(END) Dow Jones Newswires

June 23, 2023 14:50 ET (18:50 GMT)

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