Following its approval by Health Canada earlier this year, the therapy is now being commercialized in the country by Médunik Canada in partnership with Ruzurgi’s original developer, Jacobus Pharmaceutical.
Many Canadian patients were already receiving the medication under a Special Access Program, the company noted.
“Médunik Canada has plans in place to ensure a smooth transition towards a dedicated Patient Support Program (PSP) to avoid any treatment interruptions,” Dany Hallé, the company’s vice-president, commercial affairs, said in a press release.
The PSP established by Médunik Canada will assist with the treatment transition of patients who are currently taking Ruzurgi under the access program. The company has partnered with the PSP service provider Innomar to distribute the therapy.
People currently on Ruzurgi will need to register for the company’s UnikAccess PSP to receive assistance in ensuring that the medication remains accessible and affordable.
“We are proud to bring to Canadians this new option to treat this rare and debilitating disease,” said Éric Gervais, executive vice-president of Médunik Canada.
“Partnering with Innomar to present such a complete Patient Support Program is another way for us to say to impacted patients that we are here for them,” Gervais added.
LEMS, a rare autoimmune disease mainly affecting muscles in the lower limbs, is characterized by immune system attacks against a protein known as a voltage-gated calcium channel (VGCC). This protein is found at the neuromuscular junction, the site where nerve cells connect and transmit signals to muscles. Impaired nerve stimulation leads to the muscle weakness found in patients.
Ruzurgi acts by blocking potassium channels on nerve cells, so that available VGCCs stay open and send signals to increase muscle strength.
First approved by the U.S. Food and Drug Administration in May 2019 for patients ages 6 to 17, Ruzurgi is the only approved treatment available for children with LEMS.
Regulatory approval in Canada was based on positive results from clinical studies of the treatment’s efficacy and safety in adults with LEMS, as well as simulations to find the best dosing regimen for children.
In a Phase 2 trial called DAPPER (NCT01511978), treatment with Ruzurgi reduced muscle weakness in adults with LEMS. Participants taking the therapy had better scores on the Triple Timed-Up-and-Go test, which measures the time it takes for an individual to rise from a seated position, walk a short distance, and return to their seat.
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