Roche has presented new data on satralizumab for neuromyelitis optica spectrum disorder (NMOSD), setting it up for a potential market battle with Alexion’s Soliris.
The positive phase 3 study results show that satralizumab, as a monotherapy, achieved a 55% reduction in the risk of relapse in the patient population, when compared to placebo. In the overall patient population, 76.1% were relapse-free at week 48, and 72.1% were relapse-free at 96 weeks. This was in comparison to 61.9% and 51.2% in the placebo arm.
“The positive results from the pivotal SAkuraStar and SAkuraSky studies support the hypothesis that IL-6 plays a key role in this devastating disease that can take away people’s independence,” said Sandra Horning (pictured below), chief medical officer and head of global product development.
Sandra Horning
“We are encouraged by these results and look forward to working with regulators over the coming months to bring satralizumab to people living with NMOSD as soon as possible,” she added.
NMOSD disproportionately affects young women in the prime of their lives, with the average age of onset just 39 years. Another significant risk factor for disability and mortality in the condition is race.
In the US, African Americans are over-represented among patients diagnosed with NMOSD and are more likely to suffer more frequent and more severe attacks.
The condition is often confused with other neurological illnesses such as multiple sclerosis (MS), which can lead to delays in diagnosis and treatment with medicines that can actually worsen the disease progression.
Alexion’s Soliris received FDA approval in June, for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. It became the first FDA-approved treatment for NMOSD at that time, but competitors, including Roche, are hot on its heels. The positive results will likely mean that Roche is gearing up regulatory filings, with possible approval soon.
Another contender comes from Viela Bio, inebilizumab, which was filed for approval with the FDA earlier this month. Viela thinks inebilizumab has a dosing advantage over both these rivals as it can be delivered just twice a year.