Health Canada has recently granted market authorization to Hoffman La-Roche Limited for their neuromyelitis optica spectrum disorder treatment, ENSPRYNG. Canada is the first country to offer this medication, and hopefully other countries will soon follow suit.
About Neuromyelitis Optica Spectrum Disorder
Neuromyelitis optica spectrum disorder, also known as Devic’s syndrome, is an immune disorder that is characterized by inflammation of the optic nerve and spinal cord. Symptoms occur in episodes, which can have weeks or even years separating them. They include headaches, muscle spasms, blurred vision, loss of bladder and bowel control, fever, loss of appetite, abnormal sensations in the legs, weakness in the limbs, and in rare cases, uncontrollable vomiting and hiccups. All of these effects are thought to be the result of an autoimmune issue; the immune system attacks the optic nerve and spinal cord, resulting in inflammation. Why this response occurs is unknown. Studies have linked this condition to infections, such as HIV, while others have connected it to the use of certain medications. There is currently no cure or treatment specific to neuromyelitis optica spectrum disorder.
ENSPRYNG In Canada
ENSPRYNG is a monoclonal antibody that is intended to target the IL-6R receptor, as it is suspected to drive neuromyelitis optica spectrum disorder. It is administered via injection and should be taken once every four weeks. It can be taken alone or in combination with immunosuppressive therapy.
This treatment was approved based on the data from two trials, both of which were double-blind, placebo-controlled, randomized, multi-center, and Phase 3. The first, titled SAkuraStar, evaluated ENSPRYNG as a monotherapy in comparison to a placebo. The second, called SAkuraSky, studied the drug in combination with the standard of immunosuppressive therapy.
Researchers found that as a monotherapy, ENSPRYNG reduced the risk of a relapse by 74%. As a combination treatment, the risk was lowered by 79%. While adverse events were present, none were serious enough to require intervention or discontinuation of treatment. The most common were headaches, injection related reactions, and arthralgia.
Now that ENSPRYNG has been approved in Canada, Canadians with neuromyelitis optica spectrum disorder will have another treatment option. Read more about it here.