Drugs

Court Backs FDA Lumryz Approval

David McFarland

— 1 min read
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The DC federal court says FDA acted correctly in determining that Avadel CNS Pharmaceuticals’ Lumryz (sodium oxybate) is a different drug than Jazz Pharmaceuticals’ Xywav (sodium oxybate) because of a different dosing regimen, and thus correctly approved the Avadel product for marketing before Xywav finished its orphan drug marketing exclusivity. In Jazz’ suit against FDA, the court denied Jazz’ request for summary judgment and instead approved FDA’s and Avadel’s cross-motions for summary judgment.

The ruling says Jazz argued that FDA committed three errors:

  • it incorrectly concluded that Lumryz and Xywav are not the same drug, even though they have the same active moiety, but not the same dosing regimen;
  • the agency’s approval of Lumryz was arbitrary and capricious because it departed, without explanation, from longstanding agency policy requiring a new orphan drug to have comparable safety to the previously approved drug to receive approval; and
  • FDA’s determination that Lumryz was clinically superior to Xywav was arbitrary and capricious because it did not comply with internal dispute resolution procedures and because the findings were inconsistent with the scientific literature.

The court said it was not persuaded by any of Jazz’ arguments and thus held that FDA did not err in determining that Lumryz and Xywav are not the same drug, did not inexplicably depart from a “comparable safety” policy because there is no such policy; and FDA’s approval of Lumryz was not arbitrary and capricious.

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