REGENERON’S


Associated tags: FDA, Regeneron Pharmaceuticals, Casirivimab/imdevimab, Alirocumab, Immune system, Antibody, Pharmaceutical industry, Patient, Ageing, Safety, Food, Disease, Priority review, Sanofi

Praluent® (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High Cholesterol

Retrieved on: 
Monday, March 11, 2024
FDA, Gene, Patient, Regeneron Pharmaceuticals, FH, Parent, Alirocumab, Ageing, Diet, Pharmaceutical industry

“Many children with heterozygous familial hypercholesterolemia (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies.

Key Points: 
  • “Many children with heterozygous familial hypercholesterolemia (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies.
  • Familial hypercholesterolemia (FH) is an inherited condition caused by mutations in one of several genes that control how the body processes cholesterol, which can lead to very high levels of LDL-C (bad cholesterol).
  • Praluent is approved to treat both children and adults with HeFH and adults with HoFH.
  • Patients were randomized to receive Praluent (N=101) or placebo (N=52) every two or four weeks in two consecutive cohorts.

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

Retrieved on: 
Friday, February 16, 2024
Regeneron Pharmaceuticals, Ministry, Sinusitis, Omalizumab, Quality of life, Atopic dermatitis, Prurigo nodularis, MHLW, Asthma, Cell, Safety, Patient, CSU, Disease, Polyp (medicine), Pharmaceutical industry

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.

Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE)

Retrieved on: 
Thursday, January 25, 2024
Ageing, Regeneron Pharmaceuticals, Patient, Histology, Failure, Diagnosis, Medicine, Heartburn, Risk, Lower respiratory tract infection, Food, Arthralgia, Chronic pain, Safety, Disease, Esophagus, Inflammation, Helminthiasis, Priority review, FDA, Eosinophilic esophagitis, Prevalence, Vomiting, International development, Growth, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

Key Points: 
  • Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients.
  • This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40 kg.
  • Approximately 21,000 children under the age of 12 in the U.S. are currently being treated for EoE with unapproved therapies.
  • “With this approval, Dupixent becomes the first and only treatment option for EoE patients aged 1 and older, weighing at least 15 kg.

Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement

Retrieved on: 
Tuesday, January 16, 2024
Ageing, Regeneron Pharmaceuticals, Mouth ulcer, Patient, European, Conjunctivitis, Eosinophilia, Foot, Blepharitis, Keratitis, Walking, Aes, Skin, Food, Safety, Human, Inflammation, FDA, Physician, Bleeding, Atopic dermatitis, International development, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.

Key Points: 
  • These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.
  • “Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-established efficacy and safety of Dupixent in atopic dermatitis overall.”
    The label update is based on data from the Phase 3 LIBERTY-AD-HAFT trial.
  • In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66).
  • Most common adverse events (AEs) observed with Dupixent (≥1%) in atopic dermatitis include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye and eosinophilia.

Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE)

Retrieved on: 
Sunday, October 22, 2023
Abdominal pain, FDA, Adolescence, Headache, American College, Ageing, Icahn School of Medicine at Mount Sinai, Aes, Food, Injection site reaction, ACG, Priority, American College of Gastroenterology, Regeneron Pharmaceuticals, Inflammation, Eating, Priority review, Cough, PESQ, COVID-19, Mount Sinai, Eosinophilic esophagitis, Biopsy, Safety, Patient, Food and Drug Administration, Failure, Pharmaceutical industry, Vaccine, MPH, Medicine, Part, Sanofi, Dupilumab

PARIS and TARRYTOWN, N.Y., Oct. 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that positive results from a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) showed consistent efficacy and safety for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE). These results represent the first analysis of longer-term data in this age group and will be featured in a late-breaking session on October 25 at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting.

Key Points: 
  • “Dupilumab is the first and only therapeutic approved for adults and certain adolescents with EoE.
  • Some children with EoE may have sub-optimal response to currently unapproved standard of care therapies, underscoring the need for treatments targeting key pathways driving inflammation in EoE.
  • All children in Part B were treated with higher or lower dose Dupixent for an additional 36 weeks, providing up to 52 weeks of data.
  • In Part B, there were 37 patients who continued on higher dose Dupixent and 18 who switched from placebo to higher dose Dupixent.

Dupixent® (dupilumab) sBLA for Treatment of Eosinophilic Esophagitis (EoE) in Children Aged 1 to 11 Accepted for FDA Priority Review

Retrieved on: 
Tuesday, September 26, 2023
Priority review, Eosinophilic esophagitis, Diarrhea, COVID-19, Rash, Regeneron Pharmaceuticals, Gastroenteritis, Patient, Nausea, Diagnosis, Priority, Ageing, FDA, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Human, Food, Safety, Disease, Pharmaceutical industry, Vaccine, Dupilumab, Sanofi

TARRYTOWN, N.Y. and PARIS, Sept. 26, 2023 (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) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). The target action date for the FDA decision is January 31, 2024. Dupixent is the first and only treatment in the U.S. approved for children and adults aged 12 years and older with EoE, weighing at least 40kg.

Key Points: 
  • The target action date for the FDA decision is January 31, 2024.
  • Dupixent is the first and only treatment in the U.S. approved for children and adults aged 12 years and older with EoE, weighing at least 40kg.
  • The sBLA is supported by data from the Phase 3 EoE KIDS trial (Parts A and B) evaluating the efficacy and safety of Dupixent in children aged 1 to 11 with EoE.
  • Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

FDA Approves First-in-class Evkeeza® (evinacumab-dgnb) for Young Children with Ultra-rare Form of High Cholesterol

Retrieved on: 
Wednesday, March 22, 2023
Insurance, Priority review, Life, Diarrhea, Genetics, Regeneron Pharmaceuticals, Aes, COVID-19, Fear, Automotive Supplier Innovation Program, FH, ANGPTL3, Apolipoprotein, Research, Sore throat, Cough, Vomiting, Rhinitis, Hypercholesterolemia, Genetic disorder, Patient, Physician, Risk, Common, Frustration, Disease, Diagnosis, Ageing, Mortality, FDA, Fever, Headache, MPH, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Safety, Fatigue, Pharmaceutical industry, Dietary supplement, Evinacumab

TARRYTOWN, N.Y., March 22, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza® (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first angiopoietin-like 3 (ANGPTL3) inhibitor treatment indicated for children as young as 5 years old to control dangerously high levels of low-density lipoprotein cholesterol (LDL-C) caused by HoFH. Evkeeza was initially approved as an adjunct to other lipid-lowering therapies in those aged 12 years and older with HoFH in February 2021.

Key Points: 
  • Evkeeza is the first angiopoietin-like 3 (ANGPTL3) inhibitor treatment indicated for children as young as 5 years old to control dangerously high levels of low-density lipoprotein cholesterol (LDL-C) caused by HoFH.
  • With this FDA approval, the HoFH community now has a much-needed treatment for young children, potentially making it possible for many to achieve recommended LDL-C levels much earlier in the course of this rare disease.
  • “Guidelines recommend screening all children at high risk for homozygous familial hypercholesterolemia starting at age 2.
  • Significant reductions were also observed in other key secondary endpoints including levels of apolipoprotein B (ApoB), non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol.

Dupixent® (dupilumab) Late-Breaking Data at AAD Show Significant Improvements in Signs and Symptoms of Moderate-to-severe Atopic Hand and Foot Dermatitis

Retrieved on: 
Saturday, March 18, 2023
American Academy of Dermatology, Oregon Health and Science University Center for Women's Health, Clinical trial, Quality of life, American Academy, Atopic dermatitis, Regeneron Pharmaceuticals, Patient, AAD, Annual general meeting, Itch, Human, Skin, Vaccine, Pharmaceutical industry, Dupilumab, Sanofi

TARRYTOWN, N.Y. and PARIS, March 18, 2023 (GLOBE NEWSWIRE) --  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting.

Key Points: 
  • The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints.
  • The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting.
  • There were significant improvements in measures of hand and foot skin pain, sleep, and hand eczema-related quality of life.
  • The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis.

Dupixent® (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Aged 12 Years and Older Accepted for FDA Review

Retrieved on: 
Tuesday, March 7, 2023
Omalizumab, Swelling, Quality of life, FDA, Cell, Skin, Ageing, CSU, Safety, Regeneron Pharmaceuticals, Face, Disease, Hives, Angioedema, Extrapyramidal system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Food, Itch, Pharmaceutical industry, Sanofi

CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin.

Key Points: 
  • CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin.
  • Swelling, called angioedema, may occur most commonly on the face, hands and feet, but can also affect the throat and upper airways.
  • CSU is typically treated with H1 antihistamines, medicines that target histamine-1 receptors on cells to control symptoms of urticaria.
  • However, the disease remains uncontrolled in up to 50% of patients, who are left with limited alternative treatment options.