Ruzurgi (amifampridine) - authorization status

UPDATED INFORMATION – January 20, 2023 On January 10, 2023, following a Federal Court of Appeal decision, the June 24, 2021 decision of the Minister of Health on the application of the data protection provisions was restored, and a new Notice of Compliance (NOC) was issued in accordance with the Food and Drug Regulations. RUZURGI (amifampridine) is therefore authorized for sale again in Canada. Healthcare professionals should note that FIRDAPSE (amifampridine) and RUZURGI are both authorized for sale in Canada. RUZURGI is indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older. FIRDAPSE is indicated for the symptomatic treatment of LEMS in adults. Any requests that are pending for RUZURGI through the Special Access Program (SAP) will be redirected by the SAP to Médunik Canada, the company that holds the market authorization for RUZURGI. Please note that the communication issued on March 11, 2022 is no longer reflective of RUZURGI’s current market approval. UPDATED INFORMATION – March 11, 2022 On March 10, 2022, for the second time, the Federal Court set aside Health Canada’s decision to authorize RUZURGI (amifampridine), and the second Notice of Compliance (NOC) that had been issued on June 24, 2021 is considered invalid. Therefore, RUZURGI is no longer authorized for sale in Canada. Healthcare professionals should proactively contact their patients taking RUZURGI to discuss alternatives, as was communicated by Health Canada on June 10, 2021 (see below). Access to RUZURGI can be requested under the Special Access Program (SAP), where marketed alternatives are not clinically appropriate. All SAP requests should be practitioner initiated and will be considered on a case-by-case basis. The forms and instructions necessary for submitting a SAP request can be found at: www.healthcanada.gc.ca/sap. UPDATED INFORMATION – June 25, 2021 On June 24, 2021, following a Federal Court order for a new determination, a data protection decision was issued with a new Notice of Compliance (NOC) for RUZURGI (amifampridine). RUZURGI is therefore authorized for sale again in Canada. Healthcare professionals should note that FIRDAPSE (amifampridine) and RUZURGI are both authorized for sale in Canada. RUZURGI is indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older. FIRDAPSE is indicated for the symptomatic treatment of LEMS in adults. Any requests that are pending for RUZURGI through the Special Access Program (SAP) will be redirected by the SAP to Médunik Canada, the company that holds the market authorization for RUZURGI. Please note that the communication issued on June 10, 2021 is no longer reflective of RUZURGI’s current market approval. June 10, 2021 The approval for RUZURGI, a drug used for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS), was cancelled on May 31, 2021 following a Federal Court decision. Therefore, RUZURGI is no longer authorized for sale in Canada. Audiences Healthcare professionals including neurologists, immunologists and hospital pharmacists. Key messages RUZURGI (amifampridine), a drug used for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare and debilitating neuromuscular syndrome, is no longer authorized for sale in Canada. As of May 31, 2021, and following a Federal Court decision, the Notice of Compliance (NOC) is considered invalid. There are no concerns with the safety or efficacy of RUZURGI. Health Canada recommends that healthcare professionals proactively contact their affected patients about possible alternative treatment options: FIRDAPSE (amifampridine), an alternative drug product also indicated for the symptomatic treatment of LEMS in adults, is authorized for sale in Canada. There are currently no approved drug products in Canada for the symptomatic treatment of LEMS in pediatric patients. Continued access to RUZURGI can be requested under the Special Access Program (SAP) on a case-by-case basis, where marketed alternatives are not clinically appropriate. Health Canada will continue to monitor this situation closely and will update healthcare professionals should new information become available. Background information Prior to May 31, 2021, RUZURGI was indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older. LEMS, a debilitating neuromuscular syndrome, is a rare autoimmune disorder in which the immune system attacks the neuromuscular junction, interfering with the ability of nerve cells to send signals to muscle cells. RUZURGI was issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations on August 10, 2020. However, the NOC is considered invalid as of May 31, 2021, in accordance with the Federal Court Judgment in T-984-20, as a result of the application of the Food and Drug Regulations data protection provisions, and thus RUZURGI is no longer authorized for sale in Canada. There are no concerns with the safety or efficacy of RUZURGI. Information for consumers Prior to May 31, 2021, RUZURGI was used to treat the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older. Since May 31, 2021, RUZURGI is no longer authorized for sale in Canada. Affected patients should consult with their healthcare professional to discuss treatment options. Information for healthcare professionals Healthcare professionals should proactively contact their patients taking RUZURGI to discuss alternative treatment options: FIRDAPSE (amifampridine), an alternative drug product indicated for the symptomatic treatment of LEMS in adults, is authorized for sale in Canada. While RUZURGI and FIRDAPSE both contain amifampridine, the products are not identical. Changing to a new drug product should be done under the supervision of a qualified healthcare professional with knowledge of the treatment and management of LEMS. There are currently no approved drug products in Canada for the symptomatic treatment of LEMS in pediatric patients. Access to RUZURGI can be requested under the Special Access Program (SAP), where marketed alternatives are not clinically appropriate. All SAP requests should be initiated by the healthcare professional, and will be considered on a case-by-case basis. The forms and instructions necessary for submitting a SAP request can be found at: www.healthcanada.gc.ca/sap. Action taken by Health Canada Health Canada is communicating with Médunik Canada, the company who held the market authorization for RUZURGI, and the distributor to help ensure that they inform all impacted patients currently taking RUZURGI of the situation. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffectTM e-Notice email notification system. Report health or safety concerns Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any serious or unexpected side effects in patients receiving amifampridine should be reported to Health Canada. You can report any suspected adverse reactions associated with the use of health products to Health Canada by: Calling toll-free at 1-866-234-2345; or Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax. For other health product inquiries related to this communication, contact Health Canada at: Marketed Health Products Directorate E-mail: mhpd-dpsc@canada.ca Telephone: 613-954-6522 Fax: 613-952-7738

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Brand: Ruzurgi.