The EMA has granted Accelerated Assessment, and the Committee for Medicinal Products for Human Use (CHMP) is currently reviewing its MAA for satralizumab
Image: Roche files marketing applications with EMA and FDA for satralizumab. Photo: Courtesy of F. Hoffmann-La Roche Ltd.
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted to review Roche’s satralizumab in neuromyelitis optica spectrum disorder (NMOSD).
FDA has accepted Roche’s Biologics License Application (BLA) while EMA accepted the company’s Marketing Authorisation Application (MAA) for its satralizumab drug.
Satralizumab is an investigational humanised monoclonal antibody indicated for the treatment of adult and adolescent patients with NMOSD.
Roche global product development head 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 decision and CHMP recommendation are anticipated in 2020
Swiss healthcare firm said that the EMA has granted Accelerated Assessment, and the Committee for Medicinal Products for Human Use (CHMP) is currently reviewing its MAA for satralizumab.
In December 2018, the US FDA has granted Breakthrough Therapy Designation to satralizumab for the treatment of NMOSD. The drug was granted Priority Review in Canada and Switzerland, and designated as an orphan drug in the US, Europe and Japan.
NMOSD is a rare, persistent and debilitating autoimmune disorder that affects central nervous system by primarily damaging the optic nerve(s) and spinal cord, resulting in unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability in patients.
Roche said that its applications for satralizumab are based on positive results from phase III SAkuraStar and SAkuraSky clinical studies designed to evaluate the safety and efficacy of satralizumab as a monotherapy and in combination with baseline immunosuppressant therapy.
Garraway added: “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.”