Eosinophilia

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

Retrieved on: 
Lundi, janvier 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.

Dupixent® (dupilumab) Recommended for Expanded EU Approval by the CHMP to Treat Children as Young as Six Months Old with Severe Atopic Dermatitis

Retrieved on: 
Vendredi, janvier 27, 2023
European Directive on Traditional Herbal Medicinal Products, Food, Safety, Conjunctivitis, Red, European Commission, Eosinophilia, Caregiver, Quality of life, Risk, CHMP, Patient, Union, Skin, Regulation of tobacco by the U.S. Food and Drug Administration, TCS, Atopic dermatitis, Regeneron Pharmaceuticals, Siliceous ooze, European Medicines Agency, Growth, Biological soil crust, Skin infection, Pain, Birth control, Vaccine, EU, Sanofi, Lancet, Dupilumab

TARRYTOWN, N.Y. and PARIS, Jan. 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group.
  • Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers.
  • The use of Dupixent in infants and young children less than 6 years of age with severe atopic dermatitis is investigational in the EU and is not yet approved.

Press Release: Dupixent® (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis

Retrieved on: 
Vendredi, janvier 27, 2023
European Directive on Traditional Herbal Medicinal Products, Food, Safety, Conjunctivitis, Red, European Commission, Eosinophilia, Caregiver, Quality of life, Risk, CHMP, Patient, Union, Skin, Regulation of tobacco by the U.S. Food and Drug Administration, TCS, Atopic dermatitis, Siliceous ooze, European Medicines Agency, Growth, Biological soil crust, Skin infection, Pain, Birth control, Vaccine, EU, Lancet, Dupilumab

The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group.
  • Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers.
  • The use of Dupixent in infants and young children less than 6 years of age with severe atopic dermatitis is investigational in the EU and is not yet approved.

Fresenius Kabi Targets Treatment of Certain Seizures with Launch of Generic Lacosamide Injection, USP

Retrieved on: 
Jeudi, décembre 15, 2022
Mental Health, Hospitals, Cardiology, Biotechnology, Other Health, Managed Care, Health, Pharmaceutical, General Health, Maintenance, Dizziness, Conductor, Seizure, USP, Fresenius (company), Patient, Hospital, Somnolence, Headache, Hypersensitivity, Disulfiram-like drug, Nausea, Eosinophilia, FDA, ECG, UCB, CV, DRESS, Multimedia, Combination therapy, Diplopia, Pharmaceutical industry

Fresenius Kabi announced today the immediate availability in the U.S. of Lacosamide Injection, USP, a generic equivalent to VIMPAT.

Key Points: 
  • Fresenius Kabi announced today the immediate availability in the U.S. of Lacosamide Injection, USP, a generic equivalent to VIMPAT.
  • Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.
  • Fresenius Kabi produces Lacosamide Injection, USP in the United States where the company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals and health systems.
  • Fresenius Kabi Lacosamide Injection for intravenous use (CV) is indicated for the treatment of partial-onset seizures in patients 17 years of age and older.

Allakos Announces Topline Phase 3 Data from the EoDyssey Study in Patients with Eosinophilic Duodenitis

Retrieved on: 
Vendredi, septembre 9, 2022
TSS, Inflammation, Safety, IND, Stomach, SAN, Dizziness, ITT, Allergy, B cell, Eosinophilia, Headache, Bloating, EOD, Biopsy, Abdominal pain, GLOBE, Duodenum, Patient, Company, Atopic dermatitis, Population, Symptoms of COVID-19, AK002, Nausea, Flushing, Pharmaceutical industry, Medical imaging, Lirentelimab

SAN CARLOS, Calif., Sept. 09, 2022 (GLOBE NEWSWIRE) -- Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, today reported data from EoDyssey, a 24-week, Phase 3, randomized, double-blind, placebo-controlled study of lirentelimab in patients with biopsy confirmed eosinophilic duodenitis (EoD). The trial met its histologic co-primary endpoint, but it did not achieve statistical significance on the patient reported symptomatic co-primary endpoint, in both the intent to treat (ITT) population and in a prespecified subpopulation.

Key Points: 
  • Mild to moderate infusion-related reactions (including flushing, feeling of warmth, headache, nausea, and/or dizziness) occurred in 19.6% of lirentelimab-treated patients and 14.9% of placebo-treated patients.
  • Currently Allakos is not planning to conduct additional studies in eosinophilic gastrointestinal diseases, but may do so in the future.
  • Allakos is conducting a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis and a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria.
  • These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos forward-looking statements.

EMD Serono to Highlight Data at ESMO 2022 with Potential for Transformative Impact on Cancer Patients

Retrieved on: 
Mercredi, septembre 7, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Fatigue, UC, Hepatotoxicity, Liver, Pfizer, Pleural effusion, Thyroiditis, Grade 3, Maintenance, Hypothyroidism, TEN, Breathe Me, PD-1, Grade 2, Photophobia, Pulmonary embolism, PD-L1, Nausea, Patient, Avelumab, Field line, Stevens–Johnson syndrome, Incidence, Eosinophilia, Pneumonitis, Headache, Insulin, FDA, Diabetes, Hyperthyroidism, Creatinine, Diarrhea, Hyperglycemia, Kidney, Erythroderma, Pneumonia, AST, Hepatitis, Colitis, Rash, Hypophysitis, MCC, Lists of diseases, Fourth grade, Endocrinology, Hypopituitarism, Dermatitis, Degenerative disease, Prednisone, Neoplasm, HIV disease progression rates, RCC, DRESS, Brain Quest Grades 3 & 4, SJS, Infection, ALT, Edema, Merck Group, Drug, Adrenal insufficiency, Diabetic ketoacidosis, Vaccine, Pharmaceutical industry, Cytomegalovirus, Angela Merkel

Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Key Points: 
  • Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
  • Immune-mediated pneumonitis occurred in 1.2% (21/1738) of patients, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (0.3%) and Grade 2 (0.6%) adverse reactions.
  • Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including Grade 3 (0.4%) and Grade 2 (0.7%) adverse reactions.
  • Immune-mediated adrenal insufficiency occurred in 0.5% (8/1738) of patients, including Grade 3 (0.1%) and Grade 2 (0.3%) adverse reactions.

FDA approves the first treatment option for generalized pustular psoriasis flares in adults

Retrieved on: 
Jeudi, septembre 1, 2022
Flare, Fatigue, Caregiver, Research, Weakness, Urinary tract infection, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Infection, DRESS, Bruise, Board, Hope, Itch, Eosinophilia, Food, GPP, Boehringer Ingelheim, Senior, Diagnosis, Mount Sinai, Skin, Headache, Psoriasis, Excipient, Icahn School of Medicine at Mount Sinai, TB, Immune system, FDA, Vomiting, History, Risk, Tuberculosis, Prurigo, Nausea, Patient, Medical imaging, Pharmaceutical industry, Medical device, Medicine, Dermatology

We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares."

Key Points: 
  • We now have an FDA-approved treatment that may help make a difference for our patients who, until now, have not had any approved options to help manage GPP flares."
  • Distinct from plaque psoriasis, GPP is a rare and potentially life-threatening neutrophilic skin disease, which is characterized by flares (episodes of widespread eruptions of painful, sterile pustules).
  • SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) flares in adults.
  • Your healthcare provider should watch you closely for signs and symptoms of TB after treatment with SPEVIGO.

Simón Bolívar Foundation collaborates with Baylor College of Medicine to Train Venezuelan Physicians

Retrieved on: 
Mardi, avril 12, 2022
Knowledge, Academia Nacional de Medicina, Organization, Baylor College of Medicine, Multimedia, Program, Woman, Fever, Traveler, Health, Citgo, Public health, Tropical medicine, Epidemiology, Essay, Physician, Foundation, National school, Motivation, Eosinophilia, Mother, Pharmaceutical industry, Medicine, Travel, Mycology, Virology

HOUSTON, April 12, 2022 /PRNewswire/ -- The Simn Bolvar Foundation, a 501 (c)(3) non-profit private foundation, in collaboration with Baylor College of Medicine is offering to fund up to seven scholarships to medical professionals working in Venezuela for a world-class Diploma Course in Tropical Medicine from Baylor's National School of Tropical Medicine.

Key Points: 
  • HOUSTON, April 12, 2022 /PRNewswire/ -- The Simn Bolvar Foundation, a 501 (c)(3) non-profit private foundation, in collaboration with Baylor College of Medicine is offering to fund up to seven scholarships to medical professionals working in Venezuela for a world-class Diploma Course in Tropical Medicine from Baylor's National School of Tropical Medicine.
  • "We see this collaboration as the first step towards a long-term, mutually beneficial strategic relationship with Baylor College of Medicine and the Fundacin Academia Nacional de Medicina Francisco Antonio Rsquez,"said Mariela Poleo, President of the Simon Bolivar Foundation.
  • Pre-selected candidateswill be recommended to apply to Baylor College of Medicine which will have the final decision on acceptance to the program in accordance with its selection criteria.
  • The Simn Bolvar Foundation is the 501(c)(3) non-profit, private foundation of CITGO Petroleum Corporation.

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

Retrieved on: 
Jeudi, avril 7, 2022
EOS, Wheeze, Conditional sentence, Prurigo nodularis, Clinical trial, Sex, Patient, Interleukin, Skin, European Commission, Ageing, ICS, EC, Regeneron Pharmaceuticals, Eosinophilic esophagitis, The Rheumatoid Arthritis Quality of Life Questionnaire, Safety, Hope, Union, Polyp (medicine), Nitric acid, Asthma, Sinusitis, Allergic rhinitis, Maintenance, Helminthiasis, Cough, FEV1, Atopic dermatitis, Eosinophilia, Pharmaceutical industry, EU, Dupilumab

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.

New spesolimab data showed significant improvement in patients with generalized pustular psoriasis (GPP) flares

Retrieved on: 
Lundi, mars 28, 2022
Disease, BLA, University, Man, Human, The New England Journal of Medicine, Degenerative disease, Multimedia, AAD, American Academy of Dermatology, Skin, Medical Affairs Bureau, Woman, Infection, Porokeratosis, PPP, Psoriasis, HS, Pain, Food, Prevalence, Flare, Hidradenitis suppurativa, View, Quality of life, Immune system, Inflammation, Biologics license application, Boehringer Ingelheim, Safety, GPP, Sepsis, Abscess, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Priority review, Animal Health, American Academy, Alabama School of Mathematics and Science, Neutrophil, Blister, Animal, Department, Kidney, Systemic disease, FDA, Fatigue, Heart failure, Patient, Eosinophilia, Pharmaceutical industry, Vaccine, Birth control, Medicine, Dermatology

The Effisayil1 trial, recently published in The New England Journal of Medicine , showed significant clearance of skin pustules in patients with generalized pustular psoriasis (GPP) flares within the first week after treatment with spesolimab versus placebo.

Key Points: 
  • The Effisayil1 trial, recently published in The New England Journal of Medicine , showed significant clearance of skin pustules in patients with generalized pustular psoriasis (GPP) flares within the first week after treatment with spesolimab versus placebo.
  • Also, significant improvements were shown within one week in patient-reported outcomes related to pain, fatigue, quality of life, and skin symptoms after treatment with spesolimab.
  • Infections were reported by 17% and 6% of patients in the spesolimab and placebo groups, respectively (at week one).
  • "GPP has a significant impact on a patient's life, and we remain committed to bringing spesolimab to patients as quickly as possible."