Satralizumab

FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder

Retrieved on: 
Wednesday, October 30, 2019
FDA, Health, Genetics, Clinical trials, Pharmaceutical, Biotechnology, Health, Articles, Life sciences, Monoclonal antibodies, European Medicines Agency, European Union, Committee for Medicinal Products for Human Use, Food and Drug Administration, Biopharmaceutical, Biologics license application, Satralizumab, neuromyelitis optica spectrum disorder (NMOSD), satralizumab, SAkuraStar and SAkuraSky in NMOSD, Genentech in neuroscience, Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the companys Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the companys Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD).
  • The European Medicines Agency (EMA) has also validated the companys Marketing Authorization Application (MAA) for satralizumab, granting it Accelerated Assessment.
  • The FDA decision and the EMAs Committee for Medicinal Products for Human Use (CHMP) recommendation are expected in 2020.
  • A lower rate of infections (including serious infections) was observed in patients treated with satralizumab compared with the placebo group.

EMA and FDA Accept Marketing Applications for Chugai's Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Wednesday, October 30, 2019
FDA, Health, Pharmaceutical, Optical, Clinical trials, Life sciences, Articles, Health, Monoclonal antibodies, Biotechnology, Pharmacy, Satralizumab, Food and Drug Administration, Biologics license application, Biopharmaceutical, satralizumab, neuromyelitis optica spectrum disorder (NMOSD)

The U.S. Food and Drug Administration (FDA) has also accepted the Biologics License Application (BLA) for satralizumab.

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has also accepted the Biologics License Application (BLA) for satralizumab.
  • The EMAs Committee for Medicinal Products for Human Use (CHMP) recommendation and the FDA decision are expected in 2020.
  • Satralizumab is the investigational medicine that has demonstrated a clinically meaningful treatment effect as both monotherapy and add-on therapy to baseline treatment.
  • Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review.

Chugai Presents Results from Second Positive Global Phase III Clinical Study of Satralizumab in NMOSD at ECTRIMS 2019

Retrieved on: 
Thursday, September 12, 2019
Biotechnology, Health, Pharmaceutical, Clinical trials, Monoclonal antibodies, Medical research, Satralizumab, Clinical endpoint, Health, Medical specialties, Multiple sclerosis, satralizumab, neuromyelitis optica spectrum disorder (NMOSD)

NMOSD is a disease in which relapse may lead to accumulation of disabilities, and can be life-threatening.

Key Points: 
  • NMOSD is a disease in which relapse may lead to accumulation of disabilities, and can be life-threatening.
  • After experiencing a PDR or completion of the study, patients in both groups were offered treatment with satralizumab in an open-label extension period.
  • Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018 (Press release issued on October 15, 2018)
    Satralizumab, created by Chugai, is an anti-IL-6 receptor humanized recycling antibody.
  • In two global phase III clinical studies in NMOSD patients, the primary endpoint was achieved with satralizumab either as an add-on therapy to baseline treatment (NCT02028884) or as monotherapy (NCT02073279).

Genentech’s Satralizumab Significantly Reduced Relapse Risk in Second Positive Phase III Study for Neuromyelitis Optica Spectrum Disorder

Retrieved on: 
Thursday, September 12, 2019
Biotechnology, Health, Pharmaceutical, Clinical trials, Monoclonal antibodies, Autoimmune diseases, Organ systems, Satralizumab, Neuromyelitis optica, Medical specialties, Clinical medicine, Multiple sclerosis, Inebilizumab, SAkuraStar and SAkuraSky in NMOSD, neuromyelitis optica spectrum disorder (NMOSD), satralizumab, Genentech in neuroscience, Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease.
  • Satralizumab targets the IL-6 receptor, potentially offering a novel treatment approach, said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology.
  • These SAkuraStar data add to the previously reported results for satralizumab in combination with baseline therapy for people with NMOSD.
  • SAkuraStar is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab monotherapy administered to patients with NMOSD.