Treatment for neuromyelitis optica spectrum disorder (NMOSD) has transformed over the last year with FDA approvals for Alexion‘s Soliris and Viela Bio’s Uplizna, but now pharma giant Roche is entering the fray.
Roche's Enspryng, formerly known as satralizumab, scored FDA approval Friday to treat AQP4 antibody-positive NMOSD, a “devastating" neurological disease that can lead to blindness, paralysis, nerve pain, respiratory failure and more, and it's sometimes mistaken for multiple sclerosis, Kathleen Hawker, neuroscience group medical director at Roche's Genentech, said.
Enspryng will be a welcome addition to the existing treatment options for doctors and patients, Hawker said. Despite the recent Soliris and Uplizna approvals, about 40% of patients with NMOSD remain untreated. And while treatment has “come a long way," new treatment options remain “crucial,” she said.
Regulators based the green light on phase 3 data showing those who received the Roche anti IL-6 antibody experienced a 55% reduction in the risk of relapse compared with placebo. Each of the 95 trial patients had experienced a relapse in the last year. In patients with aquaporin-4 antibodies, which are found in about 80% of NMOSD patients, the drug reduced the risk of relapse by 74%.
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Roche’s Enspryng will challenge Alexion’s Soliris after that drug’s June 2019 approval in NMOSD. More recently, AstraZeneca spinoff Viela Bio won approval for Uplizna. Looking forward, Alexion’s Ultomiris—a follow-up to Soliris—is in phase 3 testing. And Roche's Rituxan or its biosimilars could be used off-label in the disease, as well, according to a previous report from Evaluate's Vantage.
But Enspryng has a key advantage over those options. It's every four weeks subcutaneously, Hawker said, so the drug can be administered in a patient's home after they’re comfortable with the process. Other medicines that treat the disease are infusions, a Roche spokesman said.
The at-home administration option could prove especially key as Roche rolls the medicine out during the COVID-19 crisis. While it’s launching amid a pandemic, the company has established a "patient navigator team" to help "answer questions, provide product education and help families understand insurance coverage and navigate appropriate financial assistance options to start and stay on Enspryng," a spokesman said. Medical communications lines will be open 24/7, he added, and the company expanded eligibility and supplies for its access program due to the pandemic.
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For Genentech, the approval comes right on the heels of Evrysdi, formerly known as risdiplam, in spinal muscular atrophy. That medicine can also be administered at home and will take on Biogen’s Spinraza and Novartis’ Zolgensma in the marketplace.