New longer-term data reinforce safety of Roche’s satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder

• Pooled data from two pivotal Phase III open-label extension (OLE) studies show satralizumab was well-tolerated as a monotherapy or in combination with baseline immunosuppressive therapy in people with neuromyelitis optica spectrum disorder (NMOSD)
• Adolescents treated with the same dosing and frequency demonstrated a benefit-risk profile generally consistent with the adult population 
• Current dosing achieved sustained suppression of IL-6 signalling over the course of four weeks
• New data further support satralizumab as a potential treatment option for NMOSD, a rare, debilitating condition with few approved treatment options
  
  

Basel, 22 May 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new pooled pivotal satralizumab safety results for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disorder. These data are being presented at the 6th Annual Meeting of the European Academy of Neurology (EAN) and show satralizumab was well-tolerated in a broad patient population – including adolescents, for whom there is no approved medicine.

Satralizumab is an investigational humanised monoclonal antibody that targets the interleukin-6 (IL-6) receptor, believed to play a key role in the inflammation that occurs in people with NMOSD. Satralizumab was designed using novel antibody recycling technology, allowing for longer duration of antibody circulation and subcutaneous dosing every four weeks.

“The open-label extension data from the Phase III studies reinforce the safety, observed tolerability and potential of satralizumab as a future treatment option for this chronic condition,” said Professor Jerome de Seze, Department Head of Neurology and Clinical Investigation Centre at the University of Strasbourg, France. “Although significant strides have been made recently in understanding NMOSD, more approved treatment options offering a well-tolerated safety profile with a less frequent, subcutaneous dosing are needed for this underserved population.”

Pooled data from the double-blind periods of the SAkuraStar and SAkuraSky Phase III studies showed that the rates of adverse events (AE) and serious adverse events (SAEs) were comparable between satralizumab and placebo groups (SAEs: 15.0 vs 18.0 events/100 patient years [PY], respectively), as a monotherapy or in combination with baseline therapy. The most common AEs in both treatment groups were urinary tract infection and upper respiratory tract infection. No deaths or anaphylactic reactions were reported.