SWITZERLAND – European Commission (EC) has approved Roche’s Enspryng (satralizumab) used to treat adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST).
ENSPRYNG is the first and only NMOSD treatment that is administered subcutaneously (injection under the skin) every four weeks, allowing home-dosing after appropriate training.
The EC approval is supported by results from two Phase III studies, in which ENSPRYNG showed robust and sustained efficacy in reducing the risk of relapse in people with AQP4-IgG seropositive NMOSD.
AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course compared to those not expressing AQP4-IgG antibodies.
“We thank the NMOSD community for their partnership and are delighted that ENSPRYNG will be available to people in the EU who until now had limited, accessible treatment options,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “Building on our growing scientific understanding of neuroimmunological conditions, we are confident ENSPRYNG can transform how people with NMOSD are treated by fitting into their day-to-day lives.”
About neuromyelitis optica spectrum disorder (NMOSD)
NMOSD is a rare, lifelong and debilitating autoimmune condition of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing permanent blindness, muscle weakness and paralysis.
People with NMOSD experience unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability though some relapse cases might result to death.
NMOSD affects over 10,000 people in Europe, up to 15,000 people in the US and approximately 200,000 people worldwide.
This condition can affect individuals of any age, race and gender, but is most common among women in their 30s and 40s, and appears to occur at higher rates in people of African or Asian background.
Although most cases of NMOSD can be confirmed through diagnostic tests, people living with the condition are still frequently misdiagnosed with multiple sclerosis.
This is due to overlapping characteristics of the two disorders, including a higher prevalence in women, similar symptoms and the fact that people can experience relapses in both conditions.
Currently, Roche is working closely with reimbursement and health technology assessment bodies in EU member states to provide access to ENSPRYNG for people who may benefit from this treatment option as soon as possible.
