Satralizumab

Genentech Announces Industry-Leading Brain Health Research Collaborations and Latest Data Across Neuroscience Medicines at AAN 2023 Annual Meeting

Retrieved on: 
Monday, April 24, 2023
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is announcing three new partnerships focused on improving brain health outcomes.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is announcing three new partnerships focused on improving brain health outcomes.
  • “With that in mind, we are committed to developing and delivering new medicines that address areas of highest need in neuroscience.
  • See AAN oral presentation details on Genentech’s telehealth pilot with Cleveland Clinic here , Tuesday, April 25 at 3:54 p.m.
  • To meet the needs of people living with brain health conditions, Genentech is continuing to grow and advance its pipeline, with key areas of focus in neuroimmunologic, neuromuscular, neurodegenerative and neurodevelopmental diseases.

Genentech to Present New Ocrevus (ocrelizumab) Data in Multiple Sclerosis and Continued Research Into Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2022

Retrieved on: 
Wednesday, October 19, 2022
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You should receive any required live or live-attenuated vaccines at least 4 weeks before you start treatment with Ocrevus.

Key Points: 
  • You should receive any required live or live-attenuated vaccines at least 4 weeks before you start treatment with Ocrevus.
  • When possible, you should receive any non-live vaccines at least 2 weeks before you start treatment with Ocrevus.
  • You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus.
  • Talk with your healthcare provider about what birth control method is right for you during this time.

Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Monday, June 28, 2021
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Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD.

Key Points: 
  • Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD.
  • We are confident that Enspryng will meaningfully contribute to improving the treatment of people with NMOSD, by fitting into their day-to-day lives.
  • Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling, which is a key driver in NMOSD.
  • Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review.

Chugai’s Enspryng Approved in Taiwan as First Approved Medicine for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Wednesday, December 9, 2020
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Chugai will cooperate with Chugai Pharma Taiwan so that Enspryng may be available to people with NMOSD in Taiwan as soon as possible.

Key Points: 
  • Chugai will cooperate with Chugai Pharma Taiwan so that Enspryng may be available to people with NMOSD in Taiwan as soon as possible.
  • The medicine is believed to prevent relapses by inhibiting the cytokine IL-6 which is a key driver in NMOSD.
  • Enspryng has been approved in Canada, Japan, Switzerland, US, Taiwan, Dominican Republic, Guyana, Indonesia, Australia and Curacao.
  • Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review.

New Data Show Genentech’s Enspryng Significantly Reduces Severity and Risk of Relapse in Neuromyelitis Optica Spectrum Disorder

Retrieved on: 
Thursday, September 10, 2020
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), will present new Enspryng (satralizumab-mwge) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), will present new Enspryng (satralizumab-mwge) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system.
  • A relapse was categorized as severe if it resulted in a change of 2 points on the Expanded Disability Status Scale.
  • SAkuraStar is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Enspryng monotherapy administered to patients with neuromyelitis optica spectrum disorder (NMOSD).
  • Enspryng is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive.

Genentech to Present New Data in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder at MSVirtual2020

Retrieved on: 
Thursday, September 3, 2020
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If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

Key Points: 
  • If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
  • If you have an active infection, your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
  • Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms.
  • Enspryng is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive.

 FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder

Retrieved on: 
Saturday, August 15, 2020
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
  • After years of dedicated effort and collaboration, the FDA approval of Enspryng exemplifies how patients, industry, and academia can find solutions together.
  • Enspryng can be administered in the home by a person living with NMOSD or a caregiver following training from a healthcare provider.
  • Enspryng is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive.

New Longer-Term Data Reinforce Safety of Genentech’s Satralizumab in Adults and Adolescents With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Retrieved on: 
Friday, May 22, 2020
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Satralizumab was designed using novel antibody recycling technology, allowing for longer duration of antibody circulation and subcutaneous dosing every four weeks.

Key Points: 
  • Satralizumab was designed using novel antibody recycling technology, allowing for longer duration of antibody circulation and subcutaneous dosing every four weeks.
  • The safety profile of satralizumab in the open-label extension (OLE) was consistent with the double-blind period with respect to the nature and rate of AEs.
  • It is highly encouraging to see the positive results from the satralizumab trial in young people with NMOSD.
  • Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, stroke, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Huntingtons disease, Parkinsons disease, autism spectrum disorder and Alzheimers disease.

Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology

Retrieved on: 
Friday, April 24, 2020
Communications, Health, Clinical trials, Publishing, Pharmaceutical, Biotechnology, Monoclonal antibodies, Medical specialties, Immunology, Immunosuppressants, Organ systems, Autoimmune diseases, Satralizumab, Neuromyelitis optica, Anti-IL-6, Inebilizumab, Tocilizumab, neuromyelitis optica spectrum disorder (NMOSD), satralizumab

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the SAkuraStar Study (NCT02073279), a global phase III clinical study of satralizumab (development code: SA237) were published on April, 22 (local time) in The Lancet Neurology.

Key Points: 
  • Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the SAkuraStar Study (NCT02073279), a global phase III clinical study of satralizumab (development code: SA237) were published on April, 22 (local time) in The Lancet Neurology.
  • Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
  • The phase III study examined the efficacy and safety of satralizumab as monotherapy for adults with NMOSD.
  • The most common adverse events in the satralizumab group were urinary tract infection and upper respiratory tract infection.

Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online

Retrieved on: 
Friday, November 29, 2019
Communications, Health, Clinical trials, Publishing, Pharmaceutical, Biotechnology, Autoimmune diseases, Health sciences, Organ systems, Medical specialties, Monoclonal antibodies, Neuromyelitis optica, Immunosuppressants, Aquaporin 4, Satralizumab, Anti-IL-6, Interleukin 6, Therapy, neuromyelitis optica spectrum disorder (NMOSD), satralizumab

Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Key Points: 
  • Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD).
  • The phase III study examined the efficacy and safety of satralizumab added to baseline therapy in patients with NMOSD.
  • The SAkuraSky study is the first clinical study to demonstrate the efficacy and safety of an investigational medicine for NMOSD regardless of AQP4-IgG expression.
  • After experiencing a PDR or completion of the study, patients in both groups were offered treatment with satralizumab in an open-label extension period.