SANOFI


Associated tags: Medicine, Science, Social responsibility, Sanofi, Patient, Pharmaceutical industry

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Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis

Retrieved on: 
Monday, March 11, 2024

The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.

Key Points: 
  • The safety profile was consistent with Part 1 of the study with amlitelimab being well-tolerated and no new safety concerns identified.
  • Overall rates of treatment-emergent adverse events (TEAEs) were 69.8% for continued amlitelimab treatment, 71.9% for the amlitelimab withdrawal-arm and 66.7% for placebo.
  • TEAEs more commonly observed included headache (11.6% amlitelimab continuation, 3.9% amlitelimab withdrawal, 6.7% placebo), upper respiratory tract infection (9.3% amlitelimab continuation, 5.5% amlitelimab withdrawal, 20% placebo).
  • Amlitelimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Press Release: Phase 2 results demonstrate rilzabrutinib rapidly reduced itch severity and significantly improved disease activity in adults with chronic spontaneous urticaria

Retrieved on: 
Saturday, February 24, 2024

Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.

Key Points: 
  • Positive results from the Phase 2 study RILECSU showed that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe chronic spontaneous urticaria (CSU), whose symptoms are not adequately controlled by H1 antihistamines.
  • Significant reduction from baseline to week 12 in weekly urticaria activity score (UAS7) [LSM -17.95 vs -11.20, respectively; p=0.0116].
  • Significant reduction from baseline to week 12 in weekly hives severity score (HSS7) [LSM -8.31 vs -4.89; p
  • Rilzabrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of COPD with Type 2 Inflammation

Retrieved on: 
Friday, February 23, 2024

TARRYTOWN, N.Y. and PARIS, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024. Regulatory submissions are under review in China and Europe.

Key Points: 
  • The target action date for the FDA decision is June 27, 2024.
  • Regulatory submissions are under review in China and Europe.
  • In both trials, Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Press Release: Filing of the 2023 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report

Retrieved on: 
Friday, February 23, 2024

Filing of the 2023 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report

Key Points: 
  • Filing of the 2023 U.S. Form 20-F and French “Document d’Enregistrement Universel” containing the Annual Financial Report
    Paris, February 23, 2024.
  • Sanofi announces today the filing of its Form 20-F with the U.S. Securities and Exchange Commission (SEC) and its “Document d’Enregistrement Universel” containing its Annual Financial Report with the French market regulator Autorité des marchés financiers (AMF).
  • These documents are available on the company’s website: https://www.sanofi.com/en/investors/reports-and-publications/financial-r...
    In addition, the Form 20-F is available on the website of the SEC ( www.sec.gov ) and the “Document d’Enregistrement Universel” is available on the website of the AMF ( www.amf-france.org ).
  • A hard copy of these documents, each of which contains our complete audited financial statements, may be received free of charge, upon request.

Press Release: Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation

Retrieved on: 
Friday, February 23, 2024

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).
  • The target action date for the FDA decision is June 27, 2024.
  • In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Press Release: Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors

Retrieved on: 
Thursday, February 22, 2024

Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors

Key Points: 
  • Sanofi’s Board of Directors proposes the appointment of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy as independent Directors
    Paris, February 22, 2024.
  • The Chairman warmly thanked them for their valued contribution to the Board of Directors and the specialized committees to which they belonged during their terms in office.
  • In 2016, Clotilde Delbos was appointed Group Chief Financial Officer and Chairman of Board of Directors of RCI Banque.
  • “The arrivals of Clotilde Delbos, Anne-Françoise Nesmes and John Sundy will strengthen the Board of Directors’ expertise in finance and science, notably in the field of immunology.

Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU)

Retrieved on: 
Friday, February 16, 2024

TARRYTOWN, N.Y. and PARIS, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy. Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

Key Points: 
  • Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
  • CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
  • CSU is typically treated with histamine-1 (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
  • In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

Press Release: Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU)

Retrieved on: 
Friday, February 16, 2024

Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

Key Points: 
  • Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.
  • CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.
  • CSU is typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
  • In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

Press Release: Phase 2 data published in NEJM show potential of frexalimab as high-efficacy therapy in relapsing MS

Retrieved on: 
Thursday, February 15, 2024

Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study.

Key Points: 
  • Findings also showed both doses of frexalimab provided significant reduction in new or enlarging T2 lesions, a secondary endpoint of the study.
  • Frexalimab is Sanofi’s novel second-generation investigational anti-CD40L antibody that has a unique method of action with the potential to address both acute and chronic neuroinflammation in MS without causing lymphocyte depletion.
  • “These published Phase 2 results for frexalimab represent important data in not only the potential treatment of MS but to the broader MS community.
  • Sanofi has initiated Phase 3 clinical trials of frexalimab in relapsing MS and non-relapsing secondary progressive MS.

Press Release: Peer support, flexible work arrangements, salary for a year: Sanofi launches global program for employees affected by cancer and critical illnesses

Retrieved on: 
Monday, February 5, 2024

Sanofi today launches ‘Cancer & Work: Acting Together’, a global program to support Sanofi employees whose lives are impacted by cancer and other critical illnesses.

Key Points: 
  • Sanofi today launches ‘Cancer & Work: Acting Together’, a global program to support Sanofi employees whose lives are impacted by cancer and other critical illnesses.
  • This program covers all Sanofi employees in the world if they are diagnosed with cancer or critical illnesses*.
  • The last thing you want to be thinking about when you are diagnosed with cancer, or going through treatment, is work.
  • The program also addresses the emotional wellbeing of Sanofi employees impacted by cancer and other critical illnesses.