Health Canada Approves Ultomiris for AChR-positive gMG
Canada follows the US, Japan, and Europe in approving Ultomiris
Ultomiris (ravulizumab-cwvz) has been approved in Canada to treat adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR), the most common type of MG-causing antibody.
The announcement came less than a year after Ultomiris was approved for the condition in the U.S., and a couple of months after receiving similar approvals in Japan and Europe.
“Continued innovation and research is the most potent tactic we have against the significant treatment burden that gMG puts on those affected by this neuromuscular disorder,” Stacey Lintern, CEO of Muscular Dystrophy Canada, said in a press release. “We’re excited about the approval of Ultomiris and for the possibility of a new and promising treatment option for gMG patients living in Canada.”
Ultomiris designed to block activation of complement cascade
In MG, the immune system launches an inflammatory attack that interferes with the communication between nerve and muscle cells, resulting in symptoms like muscle weakness.
Ultomiris is designed to block the activation of the complement cascade, a group of inflammatory immune proteins whose activation plays a central role in this autoimmune attack. The treatment works in virtually the same way as the earlier-approved MG therapy Soliris (eculizumab), but it’s designed to last longer in the body, allowing for less frequent infusions (every eight weeks instead of every two weeks). Both Ultomiris and Soliris were developed by Alexion, which is now a subsidiary of AstraZeneca.
“Since Alexion brought forward the first complement inhibitor, we’ve continued to focus on innovating in this category and really understanding the needs of people living with gMG,” said Gaby Bourbara, vice president and general manager at Alexion Canada. “Ultomiris is the only long-acting C5 inhibitor, and it will benefit a broader range of patients, including those with milder symptoms.”
Previous studies have estimated that about 263 per 1 million people in Canada — about 10,000 — are diagnosed with generalized myasthenia gravis.
We’re excited about the approval of Ultomiris and for the possibility of a new and promising treatment option for gMG patients living in Canada.
Health Canada’s approval of Ultomiris was based on data from an international Phase 3 clinical trial called CHAMPION MG (NCT03920293), which tested the therapy against a placebo in 175 adults with gMG who were positive for antibodies targeting AChR.
Results showed that Ultomiris rapidly eased symptoms, with benefits lasting for at least a year. The therapy was generally well-tolerated; the most common side effects included diarrhea and upper respiratory tract infection.
“Today’s approval represents a key step forward on behalf of the gMG community in Canada,” Bourbara said.