Health Canada’s Approval of Ruzurgi Set Aside for 2nd Time by Court

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The Federal Court of Canada has issued a decision that, for the second time, sets aside Health Canada’s approval of Ruzurgi (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 and older.

The decision is a legal victory for Catalyst Pharmaceuticals and its Canadian sublicensee, KYE Pharmaceuticals, which had challenged Ruzurgi’s approval in Canada.

“We are very pleased by the Canadian Federal Court’s decision,” Patrick McEnany, chairman and CEO of Catalyst, said in a press release.

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Judgment in Favor of Catalyst Vacates FDA Approval of Ruzurgi

The active ingredient in Ruzurgi, called amifampridine, is also the active agent in Firdapse, a therapy marketed by Catalyst that is approved in Canada to treat adults with LEMS.

In its suit, Catalyst alleged that Health Canada’s decision to approve Ruzurgi in 2020 was not valid because the application request was based on data that had been generated in studies of Firdapse. In Canada, Firdapse has been given innovative drug status, basically meaning that it is a novel compound for medical use.

Legally, data from medications given this status cannot be used to support a notice of compliance from Health Canada for the approvals of other medications until at least eight years pass following the approval of the original medicine. In its decision agreeing with Catalyst, the Federal Court set aside the notice of compliance that Health Canada had issued to Ruzurgi.

According to McEnany, the court’s decision shows “that the data submitted to support Firdapse’s [notice of compliance] in Canada was not adequately protected by the Minister due to its status as Innovative Drug.”

“This is welcome news for our company and shareholders,” he added. “Together with our partner KYE Pharmaceuticals who share our passion for addressing the needs of LEMS patients in Canada, we are well prepared to help eligible patients obtain access to this important medicine.”

This is the second time a court has struck down Health Canada’s approval of Ruzurgi. The agency re-issued a notice of compliance for Ruzurgi last year, after a court decision had struck down the original approval.

Ruzurgi’s approval in the U.S. was also struck down recently after a legal challenge from Catalyst.