SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug maker Roche Group (RHHBY) announced Thursday that new data showed its ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder or NMOSD in double-blind periods of SAkura Phase III studies.
SAkuraStar is a Phase III multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of ENSPRYNG monotherapy administered to patients with NMOSD.
The company will present new ENSPRYNG (satralizumab) data on reducing relapse severity in the treatment of NMOSD, a rare disease of the central nervous system, at MSVirtual2020, the 8th joint ACTRIMS-ECTRIMS meeting
These data are being presented at the meeting, in addition to longer-term efficacy data supporting the continued effect of ENSPRYNG on reducing the risk of NMOSD relapse, as well as its favourable benefit:risk profile.
The data for ENSPRYNG are promising and suggest it significantly reduces relapse severity and frequency, which are important goals of the treatment for people with NMOSD.
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said, 'ENSPRYNG is the first and only FDA-approved subcutaneous, self-administered medicine for NMOSD and the first medicine for NMOSD that is designed to target the interleukin-6 receptor, which is believed to play a key role in the inflammation associated with this disorder.'
ENSPRYNG is approved in Canada, Japan, Switzerland and the U.S. Additional applications are under review with numerous regulators, including in the EU and China.
ENSPRYNG has been designated as an orphan drug in the U.S., Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.
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