Back in June of this year, the FDA granted approval to UPLINZA to reduce attacks in patients with anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD). Now, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the same for Europe.
UPLINZA for NMOSD
The EMA has already granted the orphan designation to UPLINZA, and now CHMP has released its positive opinion and recommended marketing authorization. This opinion was based on positive data from the N-MOmentum program, which demonstrated that UPLINZA reduces the risk of relapse by 77% when compared to a placebo.
If all continues to move forward, UPLINZA should receive approval as a monotherapy for adult patients with AQP4-IgG+ NMOSD in Europe.
UPLINZA in the Future
NMOSD is not the only condition that is being investigated for UPLINZA. There are currently a number of clinical trials being conducted, assessing this treatment for myasthenia gravis (MG) and IgG4-related disease.
Neuromyelitis optica spectrum disorder is a rare disorder characterized by inflammation of the spinal cord and optic nerve. Symptoms appear in the form of attacks, which are followed by periods of remission. Remission can range anywhere from days to years. Symptoms include:
- Eye pain
- Vision loss
- Changes in sensory, motor, and autonomic functions
- Paralysis of the lower limbs
- Sensory loss
- Pain in the limbs and/or back
- Changes in deep tendon reflexes
- Diminished control of the bowels and bladder
Medical unprofessional are unsure of the exact cause of NMOSD, but they categorize it as an autoimmune disorder. This means that the immune system mistakenly attacks the body rather than foreign invaders. In terms of treatments, the FDA has approved three options for this condition: UPLINZA, Enspryng, and Soliris. In the case of an attack, doctors will treat patients with high doses of corticosteroids, plasma exchange, and immunosuppressive drugs.
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