Enspryng Approved for NMOSD in European Union
The European Commission has approved Enspryng (satralizumab) for the treatment of people, 12 and older, with neuromyelitis optica spectrum disorder (NMOSD) who are positive for antibodies against the aquaporin-4 protein (AQP4-IgG).
The approval covers Enspryng for use as a monotherapy (on its own) or in combination with other immunosuppressive medications.
The treatment is the first and only NMOSD therapy that is administered subcutaneously (by injection under the skin) every four weeks, according to Roche, which markets Enspryng. With proper training, subcutaneous injections can be administered at home.
“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,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in a press release.
The approval was based on findings from two Phase 3 clinical trials: SAkuraStar (NCT02073279), which assessed Enspryng monotherapy in adults with NMOSD, and SAkuraSky (NCT02028884), which tested Enspryng in combination with immunosuppressive therapy in adults and adolescents (ages 12 and up) with NMOSD.
In both trials, Enspryng treatment significantly reduced the risk of relapses, compared with a placebo, with benefits that were sustained for 96 weeks (nearly two years). The medication also was generally safe and well-tolerated. Common side effects include headache, joint pain, low levels of white blood cells, high levels of fats in the blood, and injection-related reactions.
Reducing relapses is key to NMOSD treatment, because disability tends to accumulate with relapses. In other words, a person with NMOSD is likely to have more severe impairment after a relapse, according to Friedemann Paul, MD, professor of clinical neuroimmunology at Charité Universitätsmedizin in Berlin.
“With the approval of Enspryng, we now have a treatment option with a favourable safety profile that significantly reduces relapses in AQP4-IgG seropositive adults and adolescents after their first NMOSD attack or in more advanced disease, either as a monotherapy or in combination with [immune-suppressing therapies],” Paul said. “Importantly, people with NMOSD now have the flexibility to administer treatment at home, which may alleviate the need to travel for hospital appointments.”
The company is “working closely with reimbursement and health technology assessment bodies in EU member states” to make the newly approved medication available to people who need it, according to Roche.
Enspryng is designed to block the activity of interleukin-6, which is a signaling molecule that drives inflammation in NMOSD. The medication contains an antibody that has been modified with a recycling antibody technology by Chugai, a subsidiary of Roche, allowing it to stay active in the body for longer and bind repeatedly to its target.
“Enspryng is the first approved therapeutic antibody for which our proprietary recycling antibody technology was applied,” Osamu Okuda, president and CEO at Chugai, which designed Enspryng, said in a separate release. “We are confident that Enspryng will meaningfully contribute to improving the treatment of people with NMOSD, by fitting into their day-to-day lives.”