Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of Dupixent (dupliximab) for a sixth potential indication as a supplemental biologic. Sanofi announced today that the U.S. Food and Drug Administration (FDA) has granted priority review of the Supplemental Biologics License Application (SBLA) for the sixth potential indication for dabigatran (duplizumab), an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The FDA approval is expected on June 27, 2024. China has also submitted a marketing authorization application and received acceptance from the Center for Drug Evaluation (CDE) of the State Drug Administration (SDA). Data from two Phase III clinical trials (BOREAS and NOTUS) supporting this SBLA and other applications globally evaluated the efficacy and safety of Dupixent in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) with type 2 inflammation who are smokers or have a history of ...
Don Tracy, Associate Editor Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease. Regeneron Pharmaceuticals and Sanofi have announced that a Phase 3 trial evaluating Dupixent (dupilumab) in the treatment of chronic obstructive pulmonary disease (COPD) showed the drug reduced exacerbations by 34%, reportedly confirming positive results from its earlier Phase 3 BOREAS trial. According to a Regeneron press release, the NOTUS trial also confirmed that treatment led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. Back in May, the companies also announced the success of the aforementioned BOREAS trial for investigational use of Dupixent in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with COPD and evidence of type 2 inflammation. Earlier this year, the drug was granted FDA Breakthrough Therapy designation as an add-on maintenance treatment in ...
A recent study finds that longstanding childhood second-hand smoke (SHS) exposure is linked to higher mortality in adulthood due to chronic obstructive pulmonary disease (COPD). 70,900 individuals aged 50 years and above registered from 1992-1993 to 2016-2017 who had not smoked, included in the Cancer Prevention Study–II Nutrition Cohort, provided data which was analyzed by researchers to find any link between exposure to SHS in childhood and adulthood and the mortality risk in later life. The researchers published their findings in the American Journal of Preventive Medicine, which saw that children who were exposed to SHS for about 16-18 years showed 31% more chances of mortality from COPD than children who were devoid of such exposure. Any amount of exposure to SHS in childhood showed 21% more chances of death due to COPD. “It is established that SHS [secondhand smoke] exposure in childhood can result in asthma, chronic wheezing, respiratory infections, ...
As pollution increases, so do diseases such as asthma and COPD (Chronic Obstructive Pulmonary Disease). Asthma patients face difficulty in breathing due to the narrowing of airways caused by inflammation. COPD patients, however, can be affected with chronic bronchitis which leads to restrained breathing.
Nucala (mepolizumab) was first approved as the first anti-IL5 treatment for adults and adolescents with severe asthma accompanied by eosinophilic phenotype in the United States during November 2015. Later it was approved to treat eosinophilic granulomatosis with polyangiitis (EGPA).
Chronic Obstructive Pulmonary Disease (COPD) is defined as a condition which affects airways and alveoli, leading to the loss of lung function in a progressive manner. COPD is the fourth leading cause of death globally and has affected more than 200 million people throughout the world.
Chronic obstructive pulmonary disease (COPD) is kind of lung disorder where the person may have difficulty in breathing which worsens over time. An irritation or inflammation in the lungs causes the air sacs to lose their elasticity, which leaves the air trapped in the lungs when you exhale. If this lasts too long, it could lead to a group of lung diseases (Chronic bronchitis and Emphysema) known as COPD.
GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
GSK is shifting resources towards key therapeutic classes, including respiratory disease.
Treatment with Novartis’ Ultibro Breezhaler significantly boosted lung and cardiac function in chronic obstructive pulmonary disease (COPD) patients with lung hyperinflation, trial findings show.
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