Médunik Canada once again receives Notice of Compliance from Health Canada for Ruzurgi® (amifampridine) following review ordered by court ruling
BLAINVILLE, QC, June 29, 2021 /CNW Telbec/ - Médunik Canada is pleased to announce that Health Canada has reissued the approval (Notice of Compliance) for Ruzurgi® (amifampridine), for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients six years of age or older and has resumed supply in Canada.
Médunik Canada had suspended supply following a decision of the Federal Court of Canada on May 31, 2021, related to data protection provisions. It was not related to the safety or efficacy of Ruzurgi®.
The court decision required Health Canada to reconsider the NOC it had issued on August 10, 2020. This reconsideration concluded with the reissuance of the NOC on June 24, 2021. No changes have been made to the Ruzurgi® Product Monograph.
Médunik Canada has immediately resumed the supply of Ruzurgi® to Canadian patients through its UnikAccess Patient Support Program.
"We are very pleased that this situation has been resolved quickly and satisfactorily by Health Canada so that we can resume the supply of this important treatment to Canadian patients," said Dany Hallé, Vice President, Commercial Affairs, Médunik Canada. "We are keenly aware of how crucial this treatment is to the Canadians who receive it and thank Health Canada for its rapid resolution of this situation."
LEMS is a rare disabling and life-threatening disease for which Ruzurgi® has been shown to be an effective symptomatic therapy, allowing many patients to resume an active and productive life. It is currently used by fewer than 100 patients in Canada, most in middle age but including some children. Médunik Canada ensures that all Canadian patients who need the treatment receive it no matter their financial or drug insurance status.
ABOUT LAMBERT-EATON MYASTHENIC SYNDROME (LEMS)
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. LEMS generally affects the extremities, causing muscle weakness, especially in the legs and hips, which can ultimately lead to difficulty walking. Weakness in the eye muscles and those involved in talking, swallowing and chewing may also occur. LEMS may be associated with small-cell lung cancer, where its onset precedes or coincides with the cancer diagnosis. While the prevalence of LEMS in children is not known, the disease is estimated to affect 3-4 of every 1 million individuals worldwide and can occur at any age.
ABOUT RUZURGI®
Ruzurgi® (amifampridine), indicated for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in patients 6 years of age or older is an oral potassium channel inhibitor designed to prolong signals released from nerves to allow greater stimulation of muscle. Developed by Jacobus Pharmaceutical Co., the drug known as 3,4-DAP received FDA (Food and Drug Administration) market authorization in the United States in May 2019 for the treatment of LEMS in patients 6 to less than 17 years of age. To bring the drug to Canadian patients, Jacobus partnered with Médunik Canada, which originally received market authorization from Health Canada for the drug under the brand name Ruzurgi® in August 2020.
ABOUT MÉDUNIK CANADA
Médunik Canada's vision is to improve the health and quality of life of Canadians living with rare diseases. Founded in December 2009, the company's mission is to make orphan drugs available to Canadians by partnering with international companies interested in making their products available to Canadian patients. For more information, please visit www.medunikcanada.com.
SOURCE Medunik Inc.
Marie-Philippe Busque, Capital-Image, [email protected], C: 514-660-7684
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