Dupilumab

Global Food Allergy Pipeline Market Insights Report 2022: Insights About 33+ Companies and 33+ Pipeline Drugs - ResearchAndMarkets.com

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Wednesday, April 20, 2022
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The "Food Allergy - Pipeline Insight, 2022" report provides comprehensive insights about 33+ companies and 33+ pipeline drugs in Food Allergy pipeline landscape.

Key Points: 
  • The "Food Allergy - Pipeline Insight, 2022" report provides comprehensive insights about 33+ companies and 33+ pipeline drugs in Food Allergy pipeline landscape.
  • The assessment part of the report embraces, in depth Food Allergy commercial assessment and clinical assessment of the pipeline products under development.
  • Companies and academics are working to assess challenges and seek opportunities that could influence Food Allergy R&D.
  • This segment of the Food Allergy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.

Press Release: Dupixent® (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation

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Thursday, April 7, 2022
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The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union.

Key Points: 
  • The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union.
  • Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden.
  • Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks.
  • In clinical trials, Dupixent significantly reduced asthma attacks, helped children breathe better and improved their health-related quality of life.

Press Release: Sanofi continues on path to industry leadership in Immunology with Dupixent® (dupilumab) as key driver

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Tuesday, March 29, 2022
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The focus of the event is on Dupixent (dupilumab), a key growth driver, and Sanofis rapidly advancing pipeline, highlighting dermatological, respiratory and gastrointestinal diseases as priority therapeutic areas.

Key Points: 
  • The focus of the event is on Dupixent (dupilumab), a key growth driver, and Sanofis rapidly advancing pipeline, highlighting dermatological, respiratory and gastrointestinal diseases as priority therapeutic areas.
  • By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups.
  • This truly unique medicine is only at the beginning of its journey to helping potentially millions of patients.
  • Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Press release: Late-breaking Phase 3 data at AAD 2022 show Dupixent® (dupilumab) significantly improved signs and symptoms of prurigo nodularis

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Saturday, March 26, 2022
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The companies previously announced topline results from PRIME2 and a second trial called PRIME investigating the use of Dupixent in adults with uncontrolled prurigo nodularis.

Key Points: 
  • The companies previously announced topline results from PRIME2 and a second trial called PRIME investigating the use of Dupixent in adults with uncontrolled prurigo nodularis.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indications.
  • For the 24-week treatment period, overall rates of adverse events were generally similar between Dupixent and placebo groups (57% Dupixent, 51% placebo).
  • Data from both trials will form the basis of regulatory submissions around the world for Dupixent in prurigo nodularis, which are planned to begin in the first half of 2022.

Dupixent® (dupilumab injection) now approved in Canada for the treatment of severe asthma in children aged six to 11 years with type 2 inflammation

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Monday, March 28, 2022
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The approval is based on the pivotal VOYAGE phase 3 trial which enrolled 408 children aged six to 11 years with uncontrolled moderate- to severe asthma.

Key Points: 
  • The approval is based on the pivotal VOYAGE phase 3 trial which enrolled 408 children aged six to 11 years with uncontrolled moderate- to severe asthma.
  • Dupixent has since been approved for the treatment of adolescents and children aged six and older with atopic dermatitis; adults with chronic rhinosinusitis with nasal polyposis (CRSwNP); and adults, adolescents and now children aged six and older with severe asthma.
  • Dupixent is the first medicine approved for the treatment of severe asthma with a type 2 inflammation phenotype.
  • Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma , December 9, 2021 N Engl J Med 2021; 385:2230-2240 DOI: 10.1056/NEJMoa2106567
    iii Asthma Canada: Understanding Asthma .

Late-breaking data at 2022 AAAAI Annual Meeting show Dupixent® (dupilumab) significantly improved signs and symptoms of eosinophilic esophagitis

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Saturday, February 26, 2022
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Eosinophilic esophagitis is a chronic, progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly.

Key Points: 
  • Eosinophilic esophagitis is a chronic, progressive type 2 inflammatory disease that damages the esophagus and prevents it from working properly.
  • These pivotal data will be presented today at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting during a late-breaking oral abstract session.
  • Data presented at the 2022 AAAAI Annual Meeting showed that patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo:
    64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008).
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.

Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent® (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria

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Saturday, February 26, 2022
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Detailed results from a Phase 3 trial showed that adding Dupixent (dupilumab) to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks in biologic-nave patients with chronic spontaneous urticaria (CSU) compared to antihistamines alone in this investigational setting.

Key Points: 
  • Detailed results from a Phase 3 trial showed that adding Dupixent (dupilumab) to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks in biologic-nave patients with chronic spontaneous urticaria (CSU) compared to antihistamines alone in this investigational setting.
  • These results will be presented today in a late-breaking session at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.
  • Data presented at AAAAI 2022 showed that patients who added Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (referred to as placebo) with continuous improvement out to 24 weeks.
  • CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin.

Late-breaking Data at 2022 AAAAI Annual Meeting Show Dupixent® (dupilumab) Significantly Improved Signs and Symptoms of Eosinophilic Esophagitis

Retrieved on: 
Saturday, February 26, 2022
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These pivotal data will be presented today at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting during a late-breaking oral abstract session.

Key Points: 
  • These pivotal data will be presented today at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting during a late-breaking oral abstract session.
  • Data presented at the 2022 AAAAI Annual Meeting showed that patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo:
    64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008).
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.
  • In September 2020, the U.S. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE.

Positive Dupixent® (dupilumab) Data Across Five Diseases with Underlying Type 2 Inflammation to be Presented at 2022 AAAAI Annual Meeting

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Tuesday, February 1, 2022
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The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis.

Key Points: 
  • The five diseases include eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis.
  • These include analyses in patients characterized by different type 2 inflammatory biomarkers and comorbidities, as well as those with seasonal exacerbations.
  • IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and CRSwNP.
  • To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

Second positive Phase 3 Dupixent® (dupilumab) trial confirms significant improvements for patients with prurigo nodularis

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Wednesday, January 19, 2022
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People with prurigo nodularis can experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body.

Key Points: 
  • People with prurigo nodularis can experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body.
  • Nearly three times as many Dupixent patients achieved clear or almost clear skin, a secondary endpoint: 48% of Dupixent patients compared to 18% of placebo patients (p= 0.0004).
  • Dupixent patients experienced significantly greater improvements in measures of overall health-related quality of life, skin pain, and symptoms of anxiety and depression.
  • Additionally, 0% of Dupixent patients and 4% of placebo patients discontinued treatment due to adverse events prior to week 24.