DSQ

Revolo Biotherapeutics Receives Orphan Drug Designation from the U.S. FDA for its First-in-Class Peptide as a Potential Treatment for Eosinophilic Esophagitis

Retrieved on: 
Tuesday, January 30, 2024
Principal, Immune system, Eosinophilic esophagitis, Eosinophil, Patient, Safety, Diagnosis, FDA, DSQ, MPH, Food, Autoimmunity, Blood, Disease, Revolo, Flow cytometry, University, ODD, Pharmaceutical industry

Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

Key Points: 
  • Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.
  • A statistically significant reduction in eosinophils, CD4+, and CD8+ cells from baseline as measured in esophageal tissue by flow cytometry.
  • A statistically significant increase in T regulatory cells in esophageal tissue and B regulatory cells in the blood, respectively.
  • The trial will evaluate higher dose levels of ‘1104 and a longer duration of therapy.

Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis

Retrieved on: 
Monday, January 30, 2023
Royal commission, Inflammation, Immunology, Bruise, Eosinophilic esophagitis, Safety, Conjunctivitis, European Commission, Eosinophilia, Ageing, EC, Esophagus, Medicare Part D, Patient, Union, Arthralgia, Regeneron Pharmaceuticals, DSQ, Choking, Infection, Pain, International development, Pharmaceutical industry, Medical imaging, EU, Sanofi, EOE, Dupilumab, Part

TARRYTOWN, N.Y. and PARIS, Jan. 30, 2023 (GLOBE NEWSWIRE) --  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.
    “This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union.
  • “Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.

Press Release:  Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis

Retrieved on: 
Monday, January 30, 2023
Inflammation, Bruise, Eosinophilic esophagitis, Safety, Conjunctivitis, European Commission, Eosinophilia, Ageing, EC, Esophagus, Alveolar soft part sarcoma, Patient, Union, Arthralgia, DSQ, Choking, Infection, Pain, Pharmaceutical industry, Medical imaging, EU, EOE, Dupilumab, Part

EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.
  • The safety profile through 52 weeks was generally consistent with the safety profile observed at 24 weeks.

FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

Retrieved on: 
Friday, May 20, 2022
Journal of Transportation Engineering, Part B: Pavements, Office of Inspector General, U.S. Department of Health and Human Services, Hypersensitivity, Center for Drug Evaluation and Research, Disease, Ageing, Public health, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Research, Keratitis, Arthralgia, Asthma, Sinusitis, Adolescence, Cosmetics, Parasitism, Patient, Dysphagia, Multimedia, Vaccine, China Biologic Products, Esophagus, Human services, Clinical trial, Adult, FDA, Polyp (medicine), Regeneron Pharmaceuticals, Eosinophilic esophagitis, Center, Smokeless tobacco, Animal, Dietary supplement, Safety, DSQ, Division, Allergy, Eosinophil, Maintenance, Conjunctivitis, Respiratory tract, Atopic dermatitis, Pharmaceutical industry, Part, EOE, Gastroenterology, Dupilumab

Today's action marks the first FDA approval of a treatment for EoE.

Key Points: 
  • Today's action marks the first FDA approval of a treatment for EoE.
  • "Today's approval will fulfill an important unmet need for the increasing number of patients with eosinophilic esophagitis."
  • EoE is a chronic inflammatory disorder in which eosinophils, a type of white blood cell, are found in the tissue of the esophagus.
  • In adults and adolescent patients with EoE, common symptoms include difficulty swallowing, difficulty eating, and food getting stuck in the esophagus.

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
Physician, HPF, AAAAI, Dupilumab, American Academy, Annual general meeting, Eosinophilic esophagitis, Disease, EOE, Data, DSQ, FDA, Esophagus, Asthma, Patient, Dysphagia, Pharmaceutical industry

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

Retrieved on: 
Saturday, February 26, 2022
Physician, HPF, AAAAI, NASDAQ, University, American Academy, Annual general meeting, Eosinophilic esophagitis, Disease, EOE, Data, DSQ, FDA, Esophagus, Asthma, Patient, Hepatology, Regeneron Pharmaceuticals, Dysphagia, Vaccine, Pharmaceutical industry, Dupilumab, Sanofi, Gastroenterology, Medicine

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.

Allakos Announces Topline Phase 3 Data from the ENIGMA 2 Study and Phase 2/3 Data from the KRYPTOS Study in Patients with Eosinophilic Gastrointestinal Diseases

Retrieved on: 
Wednesday, December 22, 2021
Annual report, Atopic dermatitis, EOE, Flushing, HPF, Patient, Dysphagia, Private Securities Litigation Reform Act, Ethnologue, Bloating, Abdominal pain, B cell, Securities Act of 1933, Gastrointestinal tract, EG, EOD, Dizziness, Skin, HPFS, Symptoms of COVID-19, Esophagus, Nausea, SEC, Stomach, Asthma, Securities Exchange Act of 1934, Drug Quality and Security Act, Allergy, Headache, TSS, Company, Eosinophil, Safety, Antibody, AK002, Risk, DSQ, Duodenum, Medical imaging, Pharmaceutical industry, Lirentelimab

The safety results of the trial were generally consistent with previously reported lirentelimab studies.

Key Points: 
  • The safety results of the trial were generally consistent with previously reported lirentelimab studies.
  • The randomized, double-blind, placebo-controlled Phase 3 trial of intravenous lirentelimab enrolled 180 patients with EG and/or EoD.
  • The Company plans to initiate a Phase 2/3 study in chronic spontaneous urticaria and a Phase 2 study in asthma in the middle of 2022 and Q4 2022, respectively.
  • These forward-looking statements should not be relied upon as representing Allakos views as of any date subsequent to the date of this press release.

Second Dupixent® (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease

Retrieved on: 
Monday, October 25, 2021
People, Weight gain, Depression, DSQ, Quality of life, Esophageal rupture, Disease, International development, Gastrointestinal tract, Esophagus, Inflammation, Anxiety, Interleukin, Patient, Frustration, United European Gastroenterology, FDA, Food, Asthma, Polyp (medicine), Risk, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Time, Atopic dermatitis, Allergy, Dupilumab, EOE, Skin, Regeneron Pharmaceuticals, Eosinophilic esophagitis, Eosinophil, Breakthrough therapy, Prurigo, Water, Pharmaceutical industry, Copper

EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.

Key Points: 
  • EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
  • The current standard of care for people with eosinophilic esophagitis may only provide limited relief of their symptoms.
  • We look forward to continuing to study Dupixents potential role in addressing the underlying type 2 inflammation that can lead to eosinophilic esophagitis.
  • The Phase 3, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in adolescents and adults with eosinophilic esophagitis.