The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
Avadel Pharmaceuticals filed a lawsuit against the Department of Health and Human Services, its secretary, the U.S. Food and Drug Administration, and its commissioner. The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve its narcolepsy drug, Lumryz.
On July 19, Avadel Pharma, headquartered in Dublin, Ireland, announced that the FDA had granted tentative approval to Lumryz. The company stated, “Tentative approval indicates that Lumryz has met all required quality, safety, and efficacy standards necessary for approval in the U.S. Final approval is pending disposition of U.S. Patent No. 8,731,963 (the “REMS patent”) which is listed in FDA’s Orange Book.”
The drug is a once-at-bedtime formulation of sodium oxybate for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy.
At the time, Greg Divis, Avadel’s chief executive officer, said, “Tentative approval is an important regulatory step forward and indicates Lumryz could potentially be granted final approval in 11 months or less. We believe once-at-bedtime Lumryz offers the opportunity to positively transform the lives of oxybate eligible patients living with narcolepsy.”
The company also indicated it filed a motion in the U.S. District Court of Delaware on June 23 to delist the REMS patent from the FDA’s Orange Book, noting, “A court order requiring the patent holder to delist the REMS patent from the Orange Book could provide a pathway for a final approval of Lumryz prior to June 2023.”
Avadel also was preparing a claim construction hearing scheduled for August 31 that the Court indicated was needed to rule on the patent delisting motion.
The lawsuit indicates Avadel submitted a New Drug Application (NDA) for the drug on December 15, 2020. Then, 221 days after the FDA was required to file a final decision on the NDA, the FDA instead decided on only a single detail of the NDA, finding that the patent as submitted overlapped with Jazz Pharmaceutical’s similar narcolepsy drug. This required Avadel to provide an appropriate patent certification.
The lawsuit alleges the FDA issued a tentative approval on July 18, but the patent lawsuit halted the approval. Jazz Pharmaceuticals sued Avadel over the patent on July 15, which delayed the NDA until 2023.
The lawsuit argues that the FDA’s patent decision caused Avadel irreparable financial harm because its business is “solely dependent” on the commercialization of Lumryz. The lawsuit is seeking an order to vacate the FDA’s patent decision, injunctive relief, and order the FDA to take direct final action on the patent within 14 days.
In 2021, Jazz accused Avadel of infringing on five patents related to Jazz’s own narcolepsy drug, Xyrem. Both Lumryz and Xyrem use the same active ingredient, sodium oxybate. In June 2022, Avadel countersued over Patent No. 8,731,963. Tentative approval of Lumryz was based on data from the Phase III REST-ON trial. The study demonstrated statistically significant and clinically meaningful results in patients with excessive daytime sleepiness.
Xyrem is taken in two doses per night. Lumryz requires only one dose. Divis argues that once-at-bedtime dosing could transform narcolepsy patients’ lives.
“Our extensive market research indicates Avadel is well-positioned to capture significant share of the oxybate eligible patient population which we estimate to be in excess of 30,000 patients,” Divis stated earlier this month. “We are pursuing all options to accelerate final approval on or before June 2023 and prepare for commercial launch.”
Jazz also has another narcolepsy drug, Xywav, which the FDA approved in 2020. It is a low-sodium treatment option. In Jazz’s first quarter report in May, Xywav sales increased 147% to $186.1 million, and Xyrem sales dropped 26% as more people switched to Xywav. In 2020, Xyrem brought in $1.8 billion in annual revenue.
