CHMP and FDA decisions on satralizumab for adult and adolescent NMOSD expected in 2020

The EMA has validated Roche’s Marketing Authorisation Application for satralizumab for adult and adolescent patients with neuromyelitis optica spectrum disorder with Accelerated Assessment. The FDA has also accepted Roche’s Biologics License Application for satralizumab. Satralizumab has been granted Priority Review in Canada and Switzerland, and designated as an orphan drug in Europe, Japan and the US. The recent applications come on the back of positive results from two phase III studies which evaluated the efficacy and safety of satralizumab as a monotherapy (SAkuraStar) and in combination with baseline immunosuppressant therapy (SAkuraSky).
Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, said: “People living with NMOSD experience unpredictable relapses that can cause permanent neurological damage, and although there have been significant strides recently in understanding the disease, more approved options are needed with different treatment approaches. Satralizumab has shown robust efficacy sustained for 96 weeks and significantly reduced the risk of relapse across a broad patient population, while offering self-administered subcutaneous dosing every four weeks. The FDA and EMA’s acceptances of the satralizumab applications bring us one step closer to providing a new medicine to thousands of people impacted by NMOSD, and we are working with the health authorities to make satralizumab available as soon as possible.”