Approval for Avadel Pharmaceuticals’ narcolepsy drug has been set back to 2023 on a patent issue flagged by the FDA.
The company revealed the delay in a regulatory filing this week. According to the document, the application for FT218 is on hold while Avadel adds a certification to its Risk Evaluation and Mitigation Strategies patent, which the FDA determined was inappropriate.
REMS patents are used for therapies that require a REMS program, in which the FDA requires a mitigation plan for meds that have serious safety concerns but also benefits that could potentially outweigh that risk. The patents are a way for a company to show they are in compliance with any REMS requirements. Any company that later wants to market a generic version of the drug after patent expiry must show they are in compliance with the REMS safety requirements.
The FDA would like to see an additional certification to the REMS patent added into the new drug application before approving FT218.
Avadel now expects the therapy to be approved on or before the REMS patent expires on June 17, 2023. The FDA does not necessarily have to wait for that date and could authorize FT218 sooner, the company said. The news sent Avadel’s shares down 48% to $1.72 Thursday morning, compared to a prior close of $3.38.
This is the latest delay for Avadel’s efforts to get FT218 approved. The therapy was one of the medicines snared up in the FDA’s inspection delays last year driven by outbreaks of COVID-19 that prevented the agency from completing manufacturing facility inspections. The original decision date was October 15, 2021, after Avadel submitted the application in February 2021.
Earlier this month, Avadel expressed confidence in the FDA’s work on FT218, saying “the FDA has maintained they have no outstanding questions or information requests and do not currently need any additional data,” according to the company’s first-quarter earnings results.
The application was in late-stage review, with Avadel certain of “the full approvability of FT218.”
Avadel still thinks the therapy can be beneficial to the narcolepsy community and the company “is committed to pursuing all options for FT218 to realize its full value,” according to the regulatory filing dated May 24.