Japanese drugmaker Chugai now has two positive phase 3 studies backing the efficacy and safety of the antibody satralizumab to treat neuromyelitis optica spectrum disorder (NMOSD).
Great news for the patient community of NMOSD, a rare disease that affects approximately 1-5 in 100,000 individuals.
What is Neuromyelitis Optica Spectrum Disorder?
Neuromyelitis optica spectrum disorder (NMOSD, also known as Devic’s syndrome), is an immune disorder that is sometimes confused with multiple sclerosis (MS).
Devic’s syndrome is characterized by inflammation of the optic nerve of the eye and/or the spinal cord due to attacks by the immune system. Individuals with Devic’s syndrome may have one attack that lasts days or weeks or recurrent attacks separated by weeks to years of remission.
- Loss of or blurred vision as well as problems with color recognition
- Loss of bowel and/or bladder control
- Weakness of legs and/or all four limbs ranging from mild to paralysis.
- Abnormal sensations in legs such as burning, prickling and tingling
- Muscle spasms
- Loss of appetite
- In rare cases, uncontrollable vomiting and hiccups when the brain stem is affected
On the Road to Approval
Now that Chugai has the data it needs to file satralizumab for approval, the NMOSD patient community is on the verge of a milestone:
This would be the first approved treatment for the disease!
Despite treatment with immunosuppressants, sometimes in conjunction with steroids, patients with NMOSD typically suffer frequent relapses that exacerbate symptoms and can lead to them going blind or becoming wheelchair-bound.