The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.
Researchers may have unlocked mechanism driving inflammation in rheumatoid arthritis
Active Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Atherosclerosis, Atopic Dermatitis (Eczema), Autoinflammatory Diseases, Axial Spondyloarthritis, Crohn's Disease, Immune-Inflammatory Diseases, Immune-Inflammatory Disorders, Inflammatory Diseases, Plaque Psoriasis, Psoriasis, Psoriasis, Psoriatic Arthritis, R&D, Rheumatoid Arthritis, Rheumatoid Arthritis, Scientists, TherapeuticsResearchers at Hokkaido University in Japan, in a collaboration with American scientists, may have identified neural crosstalk as the mechanism that drives widespread inflammation in inflammatory diseases, such as rheumatoid arthritis (RA), psoriasis and atherosclerosis.
UCB psoriasis drug will need to wait for US approval
Autoimmune Diseases, Biologics License Application (BLA), Complete Response Letter, FDA, Generalized Myasthenia Gravis (gMG), Humanized IgG1 monoclonal antibody, Immune-Mediated Diseases, Immunotherapeutics, Immunotherapies, Inflammatory Diseases, Lesions, Monoclonal Antibodies, Plaque Psoriasis, Plaque Psoriasis, Plaque Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis Lesions, Scalp plaque psoriasis, Scalp Psoriasis, Skin Diseases, Therapeutics, UCBThe U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis
Blockbusters, Eosinophilic Cells, Eosinophilic Esophagitis, Inflammatory Diseases, Regeneron Pharmaceuticals, Research & Development, Sanofi, Spplemental Biologics License Application (sBLA), TherapeuticsThe U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
Pfizer Inc.’s experimental treatment for an inflammatory bowel disease, acquired during 2021 as part of the company’s $6.7 billion Arena Pharmaceuticals deal, succeeded in a second late-stage study.
Regeneron, Sanofi Blockbuster Dupixent Scores Points in 5 More Indications
Asthma, Atopic Dermatitis (Eczema), Blockbusters, Chronic Idiopathic Urticaria, Chronic rhinosinusitis with nasal polyps (CRSwNP), Clinical Trials, ENT Diseases, Eosinophilic Esophagitis, Human Antibodies, Immunosuppressants, Prurigo nodularis, R&D, Regeneron Pharmaceuticals, Rhinosinusitis, Sanofi, TherapeuticsRegeneron Pharmaceuticals and Sanofi’s anti-inflammatory drug Dupixent (dupilumab) has shown to be effective against five types of type 2 inflammations, with more indications expected to surface soon.
Kyverna Therapeutics secured an additional $85 million following a successful Series B financing round to support various projects in the company’s pipeline of therapies for autoimmune and inflammatory diseases.
U.S. FDA Approves Second Indication for Skyrizi to Treat Adults with Active Psoriatic Arthritis
AbbVie, Active Psoriatic Arthritis (PsA), Adults, Anti-IL-23 monoclonal biologic antibodies, Approvals, Blockbusters, Clinical Trial Endpoints, COVID-19 Therapeutics, Inflammatory Diseases, Joints, New Indications, Plaque Psoriasis, Primary Endpoints, PsoriasisThe U.S. Food and Drug Administration approved AbbVie’s Skyrizi (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts 30 percent of patients with psoriasis.
The U.S. Food and Drug Administration approved Novartis’ Leqvio (inclisiran), the first small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at three months.
AbbVie’s Rinvoq won approval from the U.S. Food and Drug Administration for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or demonstrated an intolerance to one or more tumor necrosis factor (TNF) blockers.