Dupilumab

FDA Grants Dupixent® (dupilumab) Breakthrough Therapy Designation for Eosinophilic Esophagitis

Retrieved on: 
Monday, September 14, 2020
Health, Articles, Pharmacy, Monoclonal antibodies, Sanofi, Regeneron Pharmaceuticals, Dupilumab, Esophagitis, Breakthrough therapy, EOE, Eosinophilic esophagitis, Pharmaceutical industry

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent (dupilumab) for the treatment of patients 12 years and olderwith eosinophilic esophagitis (EoE).

Key Points: 
  • Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent (dupilumab) for the treatment of patients 12 years and olderwith eosinophilic esophagitis (EoE).
  • In 2017, Dupixent also was granted Orphan Drug Designation for the potential treatment of EoE.
  • The potential use of Dupixent in eosinophilic esophagitis is currently under clinical development, and its safety and efficacy for this indication have not been evaluated by any regulatory authority.
  • Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
    are scheduledtoreceiveanyvaccinations.Youshould notreceivea "livevaccine"ifyou aretreated with DUPIXENT.

Dupixent® (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma

Retrieved on: 
Tuesday, September 8, 2020
Respiratory therapy, Health, Monoclonal antibodies, Clinical medicine, Chronic lower respiratory diseases, Asthma, Dupilumab, Reslizumab, Brittle asthma

Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress.

Key Points: 
  • Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress.
  • These data suggest Dupixent may slow the progressive decline in lung function that many patients with moderate-to-severe asthma experience, as shown by the sustained improvement in lung function for up to three years.
  • Asthma attacks: Patients maintained a low rate of severe asthma attacks (unadjusted annualized severe exacerbation rate) with an average of 0.31-0.35 events per year.
  • In the year prior to commencing Dupixent trials, the rate of severe asthma attacks was 2.09-2.17 events per year.

DUPIXENT® (dupilumab injection) now approved by Health Canada for severe chronic rhinosinusitis with nasal polyposis

Retrieved on: 
Tuesday, August 18, 2020
Interleukins, Branches of biology, Medical specialties, Proteins, Dupilumab, Immunosuppressive drug, Tildrakizumab, Inflammatory cytokine

CRSwNP is a chronic, type 2 inflammatory disease of the upper airway that obstructs the sinuses and nasal passages.

Key Points: 
  • CRSwNP is a chronic, type 2 inflammatory disease of the upper airway that obstructs the sinuses and nasal passages.
  • DUPIXENT is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins6and is not an immunosuppressant.
  • In 2018, we invested more than $127 million in R&D in Canada, creating jobs, business and opportunity throughout the country.
  • 12 DUPIXENT Canada Product Monograph.

ARCADIA clinical studies to investigate potential new treatment for people with moderate-to-severe atopic dermatitis

Retrieved on: 
Tuesday, August 11, 2020
Medical specialties, RTT, Immunology, Clinical medicine, Type I hypersensitivity, Monoclonal antibodies, Atopic dermatitis, Atopy, Dermatitis, T helper cell, Allergy, Dupilumab

It is characterised by an allergic response driven by a subset of immune cells called Type 2 helper T cells.

Key Points: 
  • It is characterised by an allergic response driven by a subset of immune cells called Type 2 helper T cells.
  • Dr. Jonathan Silverberg, MD, PhD, MPH.said: "It is crucial that we continue to research new treatment options for moderate-to-severe atopic dermatitis.
  • ARCADIA 1 & 2 are identical Phase 3 randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of nemolizumab (CD14152) in subjects with moderate-to-severe atopic dermatitis.
  • The studies will also be evaluating the efficacy and safety of maintenance treatment with nemolizumab for up to an additional 32 weeks.

DUPIXENT® (dupilumab) receives positive recommendation from INESSS for the treatment of moderate-to-severe atopic dermatitis in adolescents

Retrieved on: 
Tuesday, July 14, 2020
RTT, Medical specialties, Immunology, Health, Monoclonal antibodies, Breakthrough therapy, Dupilumab, Régie de l'assurance maladie du Québec, Atopic dermatitis, Dermatitis, Sanofi

"The impact that moderate-to-severe atopic dermatitis has both physically and emotionally on patients is significant, and it can be even more devastating for adolescents during their formative years," said Marissa Poole, Country Lead, Sanofi Canada and General Manager, Sanofi Genzyme Canada.

Key Points: 
  • "The impact that moderate-to-severe atopic dermatitis has both physically and emotionally on patients is significant, and it can be even more devastating for adolescents during their formative years," said Marissa Poole, Country Lead, Sanofi Canada and General Manager, Sanofi Genzyme Canada.
  • "With this recommendation from INESSS, adolescents, and their caregivers who often play an integral role in helping to manage their disease, will now have access to DUPIXENT."
  • DUPIXENTis currently reimbursed by the Rgie de l'assurance maladie Qubec (RAMQ)ii and by the Non-Insured Health Benefits (NIHB) program for patients over the age of 18 with moderate to severe atopic dermatitis.
  • With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

FDA approves new Dupixent® (dupilumab) pre-filled pen designed to support more convenient self-administration

Retrieved on: 
Friday, June 19, 2020
Drugs, Breakthrough therapy, Dupilumab, Sanofi, Health sciences, Health care

and TARRYTOWN, N.Y., June 19, 2020 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent (dupilumab).

Key Points: 
  • and TARRYTOWN, N.Y., June 19, 2020 /PRNewswire/ --The U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent (dupilumab).
  • This new pre-filled pen will provide patients with a more convenient option for administering Dupixent.
  • "The Dupixent pre-filled pen was developed based on patient input and offers the latest technology, including visual and audio cues, to help provide support when taking this medicine."
  • "The Dupixent pre-filled pen was specifically designed to provide patients with an easy-to-use, convenient option so they can feel more comfortable administering their injections."

Cara Therapeutics Announces Completion of Interim Statistical Assessment for KARE Phase 2 Trial of Oral KORSUVA™ in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus

Retrieved on: 
Wednesday, June 17, 2020
RTT, Chemical compounds, Atopic dermatitis, Type I hypersensitivity, Medical specialties, Immunology, Monoclonal antibodies, Dupilumab, Tradipitant

Pruritus treatment continues to be a significant unmet need for patients with atopic dermatitis and we believe Oral KORSUVA has the potential to be a first-in-class anti-pruritic product with a favorable safety profile.

Key Points: 
  • Pruritus treatment continues to be a significant unmet need for patients with atopic dermatitis and we believe Oral KORSUVA has the potential to be a first-in-class anti-pruritic product with a favorable safety profile.
  • The KARE Phase 2 trial is a randomized, double-blind, placebo-controlled study that is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 410 adult subjects with atopic dermatitis.
  • Oral KORSUVA has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

AMCP Foundation P&T Competition Marks 20 Years; Winning Teams Develop Formulary Recommendations for Asthma Treatment

Retrieved on: 
Thursday, May 28, 2020
Health, Academy of Managed Care Pharmacy, Dupilumab, Sanofi, Formulary

Eight national finalist teams were identified and invited to narrate their slides for virtual review by AMCP Foundation judges.

Key Points: 
  • Eight national finalist teams were identified and invited to narrate their slides for virtual review by AMCP Foundation judges.
  • Competition teams examine a dossier in the AMCP Format for Formulary Submissions to evaluate evidence on the study drug as they develop a monograph and presentation for defending their recommendations.
  • The AMCP Foundation thanks Sanofi US Services, Inc., for use of the dossier for DUPIXENT (dupilumab) injection for this competition.
  • Established in 1990, the 501(c)3 nonprofit AMCP Foundation is the philanthropic arm of the Academy of Managed Care Pharmacy (AMCP).

FDA Approves Dupixent® (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis

Retrieved on: 
Tuesday, May 26, 2020
RTT, Medical specialties, Immunology, Type I hypersensitivity, Steroids, Monoclonal antibodies, Dermatitis, Atopic dermatitis, Dupilumab, Atopy, Sodium hypochlorite washes, EpiCeram

"This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis.

Key Points: 
  • "This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis.
  • The FDA previously granted Breakthrough Therapy designation to Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years of age not well controlled on topical prescription medications.
  • In the trial, children treated with Dupixent and TCS experienced significant improvements in overall disease severity, skin clearance and itch.
  • It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age.

Sanofi: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis

Retrieved on: 
Tuesday, May 26, 2020
Medical specialties, Medicine, Immunology, RTT, Type I hypersensitivity, Monoclonal antibodies, Corticosteroids, Dermatitis, Dupilumab, Atopic dermatitis, Atopy, Asthma

This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis.

Key Points: 
  • This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis.
  • We continue to study Dupixent in even younger children with uncontrolled moderate-to-severe atopic dermatitis from 6 months to 5 years old, as well as in children with uncontrolled, persistent asthma.
  • The FDA previously granted Breakthrough Therapy designation to Dupixent for the treatment of severe atopic dermatitis in children 6 months to 11 years of age not well controlled on topical prescription medications.
  • Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that often appears as a rash on the skin.