EMA has recommended granting a marketing authorisation in the European Union (EU) for Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adults and adolescents from 12 years of age who are positive for anti-aquaporin-4 antibodies (AQP4-IgG).
NMOSD is a rare and life-threatening condition and most commonly affects the optic nerves and spinal cord. This disorder can lead to reduction or loss of vision, loss of sensation, loss of bowel and bladder control, weakness and paralysis of the arms and legs. NMOSD is thought to be caused by an abnormal reaction of the immune system that causes damage to healthy nerve cells. It is characterised by relapsing attacks, with symptoms coming back periodically. It is estimated that NMOSD affects approximately 1-2 in 100,000 people in the EU.
Enspryng works by reducing and preventing the attacks caused by NMOSD. Satralizumab, the active substance contained in Enspryng, is an antibody designed to block the inflammatory effects of interleukin-6 receptor (IL-6), which is involved in the pathogenesis of the NMOSD.
Enspryng will be available as a pre-filled syringe and will be administered as a solution through an injection under the patient’s skin (subcutaneously). The first three injections are given two weeks apart followed by one injection every four weeks. It can be used on its own or in combination with medicines that reduce the activity of the immune system (immunosuppressive therapy).
In NMOSD, there is inflammation or damage to the optic nerves, spinal cord, and/or brain. The majority of people with NMOSD produce antibodies to a protein called aquaporin-4 (AQP4).
Inflammation is the body’s natural response to foreign organisms and is normally a way to fight infection and promote healing. But in NMOSD, the body’s immune system mistakes normal tissue in the CNS as something harmful and begins to attack the optic nerves and spinal cord, causing symptoms and injury.
Repeated inflammation within the CNS can result in relapses that may be severe and unpredictable. During a relapse, new damage to the optic nerves and/or spinal cord can occur.