Catalyst Still Expecting Firdapse Approval in Canada in 2020

Despite the COVID-19 pandemic, Catalyst Pharmaceuticals is still expecting Firdapse (amifampridine) to be approved for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in Canada later this year, the company announced in an update.

The company’s new drug submission (NDS) to Health Canada seeking approval of Firdapse for this indication already has been accepted and given priority review.

The company also stated that it is not anticipating disruptions to the supply or production of Firdapse. As previously reported, Catalyst has completed several manufacturing campaigns to ensure its Firdapse inventory will last until June 2021. The company also added that new manufacturing campaigns are underway.

With 46 more patients receiving Firdapse prescriptions during the first quarter of 2020, the company said it now has a solid base of patients on reimbursed Firdapse who are complying with their treatment regimen during the pandemic.

Catalyst also implemented a series of measures to ensure the safety of its employees during the pandemic, including travel restrictions and remote work policies.

It entered into a collaboration with the First Responders Children’s Foundation’s COVID-19 Emergency Response Fund, to develop an emergency grant program to support healthcare professionals and their families.

“I am very proud of the way that the entire Catalyst team has quickly responded and adapted in these challenging and unprecedented times to ensure the safety of all employees, while still providing uninterrupted access to Firdapse for LEMS patients and continuing our support with their healthcare providers, albeit remotely,” Patrick J. McEnany, chairman and CEO of Catalyst, said in the press release.

“We entered 2020 with a very clear operational plan to drive the growth of the Firdapse franchise, advance our clinical development programs, including MuSK antibody positive Myasthenia Gravis [MuSK-MG], and secure our supply chain and safety stock of Firdapse. We have made progress against all of these objectives and our first quarter results reflect the solid execution of this plan,” McEnany added.

The company also remains on track to report top-line findings from clinical trials of Firdapse in spinal muscular atrophy type 3 (NCT03781479, still enrolling participants) and MuSK-MG (NCT03304054) before the end of this year.

Later this year or in early 2021, Catalyst is planning to submit a supplemental new drug application (NDA) to the U.S. Food and Drug Administration seeking regulatory approval of Firdapse for MuSK-MG, pending the successful completion of this Phase 3 trial called MSK-002.