Non-cystic fibrosis bronchodilatorinis (NCFBE) innovative drug! FDA grants DPP1 inhibitor brensocatib breakthrough drug qualification!
Last Update: 2020-06-17
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, June 09, 2020 /PRNewswire-BIOON/ -- Insmed is a global biopharmaceutical company dedicated to changing the lives of severely rare patientsRecently, the company announced that the U.SFood and Drug Administration (
FDA) has granted brensocatib (formerly in1007) breakthrough drug qualification (BTD) for the treatment of adult non-cystic fibrosis bronchodilatal disease (NCFBE) to alleviate the deterioration of the diseaseCurrently, there is no specific treatment for NCFBEbrensocatib is a new, oral, reversible, dipeptide peptidease 1 (DPP1) inhibitor that is currently being developed to treat bronchodilatorism and other inflammatory diseasesBreakthrough Drug Qualification (BTD) is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug can significantly improve the condition compared to existing therapeutic drugsDrugs that acquire BTD are developed with closer guidance, includingFDAsenior officials, and are eligible for rolling and priority reviews of new drug launches to ensure new treatment options are available to patients in the shortest possible timefdaawarded brensocatib BTD, based on the results of the WILLOW II studyThis is a global randomized, double-blind, placebo-controlled study conducted in adult patients with NCFBE and evaluated the efficacy and safety of brensocatibresults showed that the study reached the primary endpoint: within 6 months of treatment, the risk of one dose (10 mg and 25 mg) of brensocatib treatment group decreased by 40% (10mg p-0.027, 25mg p-0.044) compared to the placebo groupIn addition, the study reached a critical secondary endpoint: two doses (10 mg and 25 mg) of the lung exacerbation frequency decreased by 36% (p-0.041) and 25% (p-0.167) compared to the placebo groupas mentioned earlier, the full results of the study will be presented at the American Thoracic Society (ATS) VirtualClinical Trialsmeetingon June 24, 2020non-cystic fibrosis bronchodilatal disease (NCFBE) is a severe chronic lung disease in which bronchial almost dilation occurs permanently due to the circulation of infection, inflammation and damage to lung tissueThe disease is characterized by frequent lung deterioration that requiresantibiotics
treatment and/or hospitalizationSymptoms of the disease include chronic coughing, excessive sputum secretion, shortness of breath, and repeated respiratory infections, which can worsen the underlying diseaseNCFBE affects about 34-52 million patients in the United StatesCurrently, there is no treatment specifically for NCFBE in the United States, Europe, and Japan
brensocatib is a small molecule developed by Insmed to treat bronchodilatorid I (DPP1) inhibitorsDPP1 is an enzyme that activates neutrophil serine protease (NSP), such as neutrophil elastinase, when neutral granulocytes form in the bone marrowneutrophils are the most common white blood cell types and play an important role in pathogen destruction and inflammation regulationIn chronic inflammatory lung disease, neutrophils accumulate in the airways, causing overactive NSP, causing damage and inflammation of the lungsbrensocatib may reduce the damaging effect of inflammatory diseases such as bronchial dilation by inhibiting DPP1 and its activation of NSP Insmed expects to launch the brensocatib phase III project for bronchodilatal disease in the second half of 2020 (BioValleyBioon.com) original source: InsmEd Receives THE FDA
Therapy For Brensocatib in Patients Non-Cystic Fibrosis Bronchiectas (NCFBE)
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