FDA approves Enspryng for neuromyelitis optica spectrum disorder
Click Here to Manage Email Alerts
The FDA has approved Enspryng for adults with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder, according to a Genentech press release.
Enspryng (satralizumab-mwge) is the first subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD) that can be administered by the patient or caregiver at home after receiving training from a health care provider. The treatment is given every 4 weeks after the initial loading dose.
It is designed to target and inhibit interleukin-6 receptor activity. FDA approval was based on results from two randomized, controlled phase 3 clinical trials. In the SAkuraStar and SAkuraSky studies, the therapy showed sustained efficacy and a favorable safety profile. Results were sustained for 96 weeks, and study subjects demonstrated a reduced risk for relapse compared with subjects treated with a placebo when used with baseline immunosuppressant therapy. The most common adverse effects include nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue and nausea.
Genentech intends to make the therapy available in the United States in about 2 weeks.
In June, Enspryng was approved in Japan.
Perspective
Back to Top
Rebecca Romero, MD
It is an interesting time for this medication to be approved given the ongoing pandemic.
It allows patients to administer these medications at home, therefore reducing their trips to an infusion center, like other therapies require. I also think it gives the patients with this disease, which can be devastating, another option. Until 1 year ago, we had no FDA-approved therapies for this disease, which primarily attacks the optic nerves and spinal cord. When it attacks the optic nerves, the attack can be quite devastating, leaving patients with vision deficits or even permanently blind, Even some of the attacks on the spinal cord, if they go high enough into the brainstem, can cause death. Quick and rapid diagnosis is instrumental in determining which medication these patients should be put on, because neuromyelitis optica spectrum disorder (NMOSD) is often confused with multiple sclerosis. There has been literature to show that medication for MS can provoke an NMOSD attack, so getting the diagnosis correct is at the heart of treating this disease. Having more options has been a blessing.
Read more about
Click Here to Manage Email Alerts