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 ...
Sanofi and Regeneron have shared positive results from a late-stage trial of Dupixent (dupilumab) in chronic obstructive pulmonary disease (COPD). The phase 3 NOTUS trial has been evaluating the investigational use of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled COPD and evidence of type 2 inflammation. The trial met its primary endpoint, with Dupixent shown to reduce moderate or severe acute COPD exacerbations by 34% compared to placebo. Results from the interim analysis also demonstrated that Dupixent improved lung function from baseline by 139ml at 12 weeks compared to 57ml for placebo, with this benefit sustained at week 52. COPD is a chronic respiratory disease that causes lung function to progressively decline. Approximately 300,000 people in the US live with uncontrolled cases of the condition and evidence of type 2 inflammation. The positive readout from NOTUS builds on the previous results from the ...
Researchers from the universities of Oxford, Nottingham and King’s College London (KCL) have shown that a new heart disease calculator can accurately predict an individual’s ten-year risk of cardiovascular diseases and identify high-risk patients. Published in Nature Medicine, the QR4 tool could save over 2,500 chronic obstructive pulmonary disease (COPD) patients a year, promoting earlier recognition of the disease and its associated cardiovascular risk. Currently the leading cause of death globally, CVDs are responsible for an estimated 17.9 million deaths each year, according to the World Health Organization. They are disorders of the heart and blood vessels. Researchers from KCL, along with the QRISK team based at the universities of Oxford and Nottingham, conducted a large-scale epidemiological study involving over 13 million UK citizens, which revealed an increased risk of severe cardiovascular events in female patients with COPD. The team identified seven new unique risk factors common to all genders ...
A pair of internationally renowned stem cell cloning experts at the University of Houston is reporting their findings of variant cells in the lungs of patients with Idiopathic Pulmonary Fibrosis (IPF) which likely represent key targets in any future therapy for the condition. IPF is a progressive, irreversible and fatal lung disease in which the lungs become scarred and breathing becomes difficult. The rapid development and fatal progression of the disease occur by uncertain mechanisms, but the most pervasive school of thought is that IPF arises from recurrent, subclinical lung injury that imparts changes to epithelial and stromal cells, which, in turn, compromise lung repair and favor fibrosis. To dig deeper into the cause of IPF, Frank McKeon, professor of biology and biochemistry and director of the Stem Cell Center, and Wa Xian, research associate professor at the center, used single cell cloning technologies to generate libraries of basal stem ...
According to the World Health Organization, more than half (54%) of the world's 56.4 million deaths in 2015 were caused by ten major health issues including heart disease, accidents and cardiovascular-cerebrovascular diseases.
AstraZeneca and Imperial College London have announced plans to work together on investigating the scientific mechanisms and underlying drivers of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).
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.
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.
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