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EC approves Chugai’s Enspryng for NMOSD treatment pharmaceutical-technology
June 29, 2021
The European Commission (EC) has approved Chugai Pharmaceutical’s Enspryng (satralizumab) to treat anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD).
Highlights of the EMA’s human medicine committee meeting, April 2021 europeanpharmaceuticalreview
April 27, 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
Roche’s Enspryng leads latest CHMP recommendations pharmatimes
April 27, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended eight new medicines for approval in its April meeting.
FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord americanpharmaceuticalreview
August 21, 2020
The U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive.
Roche receives FDA approval for Enspryng to treat NMOSD pharmaceutical-technology
August 18, 2020
Roche has received approval from the US Food and Drug Administration (FDA) for Enspryng (satralizumab-mwge) to treat adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
US FDA approves Enspryng from Genentech for neuromyelitis optica spectrum disorder expresspharma
August 17, 2020
In two randomised controlled Phase III clinical trials, SAkuraStar and SAkuraSky studies, Enspryng demonstrated robust and sustained efficacy and a favourable safety profile in adults with AQP4 antibody-positive NMOSD.