Roche: Enspryng approved in Japan
(CercleFinance.com) - The Swiss pharmaceutical group Roche has announced that Enspryng (satralizumab) has been approved in Japan for adults and children with neuromyelitis optica spectrum disorder.
Enspryng is the first and only treatment approved in Japan for adults and children with neuromyelitis optica spectrum disorder (OND), the company said. It is also the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks.
"Enspryng demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy (IST), and is dosed subcutaneously every four weeks," the group said.
“Today's approval in Japan is the first for Enspryng in Asia, providing a new treatment option to help reduce NMOSD relapses that cause irreversible disability, such as vision loss and paralysis,” said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
Enspryng is the first and only treatment approved in Japan for adults and children with neuromyelitis optica spectrum disorder (OND), the company said. It is also the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks.
"Enspryng demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy (IST), and is dosed subcutaneously every four weeks," the group said.
“Today's approval in Japan is the first for Enspryng in Asia, providing a new treatment option to help reduce NMOSD relapses that cause irreversible disability, such as vision loss and paralysis,” said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
Copyright (c) 2020 CercleFinance.com. All rights reserved.