According to a story from BioSpace, Chugai Pharmaceutical Co., Ltd. has recently announced that the Marketing Authorisation Application for the its drug satralizumab has been accepted by the European Medicines Agency (EMA). The drug is in development as a treatment for neuromyelitis optica spectrum disorder (NMOSD). The EMA has also given this medication Accelerated Assessment status. In addition, the company’s Biologics License Application was also recently accepted by the US Food and Drug Administration (FDA).
About Neuromyelitis Optica
Neuromyelitis optica spectrum disorders (NMOSD) is a term meant to include both neuromyelitis optica patients and those that lack the APQ4 auto antibody but still present similarly otherwise. This disorder is also known as Devic’s disease. It is characterized by inflammation of the optic nerve and spinal cord along with destruction of the myelin sheath, an insulating, protective layer surrounding nerve cells. It is considered an autoimmune disease in which the immune system mistakenly begins attacking parts of the body. It is frequently associated with other diseases, such as viral infection and antiMOG associated encephalomyelitis, the latter of which can be a direct cause in some cases. Symptoms include blindness, urinary incontinence, spastic paralysis of the legs and arms, reduced sensation, and overall muscle weakness. Symptoms can be treated, but many patients are left with a degree of impairment. To learn more about neuromyelitis optica, click here.
The Road to Approval
Decisions in regards the official approval of the drug are expected to occur next year. Accelerated Assessment status will reduce the time that it will take for the EMA to make a final decision on satralizumab. The acceptance of these applications follows the completion of two phase 3 clinical trials testing satralizumab, both on its own and as a supplement to existing treatments. The drug appeared effective in both studies, yielding positive results.
Satralizumab is designed as an anti-IL-6 receptor antibody. This mechanism of action should allow treatment with the drug to reduce the chance of the patient experiencing disease relapse as IL-6 signaling activity has been implicated in the pathology of neuromyelitis optica spectrum disorders. The drug has earned orphan drug status in the EU, Japan, and the US. In addition, it was given Breakthrough Therapy designation from the FDA.