FDA Delay Lawsuit 30 Sep 2022

FDA Delay Lawsuit

The HHS and the FDA have faced accusations of stalling and consequently a lawsuit  by the developer of a narcolepsy drug. Avadel CNS Pharmaceuticals is to sue both organisations, and their chiefs, over the delay in the approval of Lumryz.

News of the delay caused a drop in share value of 48% for Avadel and it’s also facing a drop of over 40% since January of this year.

The lawsuit is based on whether Lumryz would infringe on one of the patents that protect another narcolepsy treatment – Xywav produced by Jazz Pharmaceuticals – which has been a primary treatment since 2022 and is distributed under a Risk Evaluation and Mitigation Strategy (REMS) – a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Lumryz is based on the same active ingredient to Xywav, but isn’t identical to it, according to the lawsuit and information about potential overlap between the two was submitted to the FDA when the initial NDA application was made by Avadel in late 2020. The FDA ordered a patent certification to be completed which Avadel did earlier this year, upon which the FDA explained that final approval would be “made effective immediately, unless an action is brought for infringement of one or more of the patents that were the subject of a paragraph IV certification” by July 22, 2022. It was eventually delayed well into 2023.

To further complicate matters, Jazz filed a lawsuit against Avadel for alleged patent infringement. Both factors – the FDA’s ‘erroneous’ patient decision, and the Jazz lawsuit – have led Avadel to allege that they have been caused significant and irreparable harm. Their lawsuit says that the FDA erred under the Administrative Procedure Act in requiring Avadel to submit a patient certification and that the FDA lacks authority to second guess an NDA applicant’s decision concerning what type of patent certification or statement to submit.

Avadel is requesting that the court order the patent decision to be set aside and as well as injunctive relief enjoining the FDA from requiring Avadel to submit patent certification along with an order directing them to take final action on the NDA within 14 days of the court’s order.

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