Roche’s new approval Enspryng cuts relapse risk in NMOSD—and provides extended benefits
Squaring off against Alexion and AstraZeneca spinoff Viela Bio with a new treatment in neuromyelitis optica spectrum disorder (NMSOD), Roche is touting new data analyses for its Enspryng that show a dramatic reduction in the risk of severe relapses, plus benefits of extended treatment.
In an analysis of two previously published Phase 3 studies comprising 178 NMOSD patients, those who received Enspryng saw a 79% lower risk of severe relapse compared with those on placebo, Roche said. Enspryng, approved last month, is the only NMOSD treatment option that can be taken in a patient’s home.
And in a separate analysis, the Swiss drugmaker touted pooled data that showed the drug reduced NMOSD patients’ relapse risk over a longer period during open-label study extensions. That risk reduction was 51% compared with patients in the original placebo group, but for patients with the aquaporin-4 antibody, the risk reduction was 66%.
NMOSD is a devastating neurological disease, sometimes mistaken for multiple sclerosis, that can lead to blindness, paralysis, nerve pain, respiratory failure and more. The primary goal of treatment is to prevent relapses, which if severe can cause irreversible neurological damage and disability.
One phase 3 trial ran for 1.5 years after the last patient enrollment, and the other was event-driven and ran until there were 26 relapses. Roche didn’t immediately say how long the open-label extension periods ran. The company is presenting the data in connection with the MSVirtual2020 annual meeting this weekend.
In all, the data “further reinforce the previously observed efficacy of this medicine for this debilitating disorder that is often mistaken for multiple sclerosis,” Roche chief medical officer Levi Garraway said in a statement.
Roche’s Enspryng won FDA approval last month to treat AQP4 antibody-positive NMOSD, entering a field featuring treatments from Alexion and Viela Bio. Looking forward, Alexion’s Ultomiris is in phase 3 testing in NMOSD.
Despite the recent approvals for Soliris and Uplizna in NMOSD, about 40% of patients remain untreated, Kathleen Hawker, neuroscience group medical director at Roche’s Genentech, previously said. While treatment has “come a long way,” new treatment options remain “crucial,” she said.