Search Results for “COPD” – media

Another new COPD drug is coming

On September 6, GlaxoSmithKline (GSK) announced that its Phase 3 MATINEE study of its IL-5 antibody Nucala (mepolizumab) in the treatment of COPD achieved positive results. Compared with the placebo group, the Nucala treatment group achieved a statistically significant reduction in the annualized rate of moderate to severe exacerbations, but specific data have not yet been released. Two months ago, two COPD drugs with new mechanisms: ensifentrine and dupilumab were approved for marketing in the United States and Europe, refreshing the treatment model of this severe respiratory disease. Mepolizumab is expected to join this new round of competition. COPD: The third leading cause of death in humans Chronic obstructive pulmonary disease (COPD), referred to as COPD, is a common, preventable and treatable heterogeneous disease. According to statistics from the World Health Organization, COPD has become the third leading cause of death in humans, with about 11% of people dying from ...
- Source: drugdu
- 67
- September 14, 2024
Sanofi & Regeneron Drug Dupixent Gets EMA Approval as the First Biologic COPD Med

European Medicines Agency approval of Dupixent in chronic obstructive pulmonary disease makes the drug the first biologic therapy approved for treating the prevalent respiratory condition. In COPD, Dupixent addresses what’s called type 2 inflammation. By Frank Vinluan Inflammation that develops in chronic obstructive pulmonary disorder stems from different causes. A new regulatory decision in Europe makes Sanofi and Regeneron Pharmaceuticals drug Dupixent the first biologic therapy approved for COPD driven by one particular type of inflammation. The European Medicines Agency (EMA) has approved Dupixent for adults with uncontrolled COPD that is also characterized by raised blood levels of eosinophils, a type of white blood cell. COPD patients typically take multiple medications to manage the chronic condition. The new Dupixent approval, announced just prior to the Independence Day holiday in the U.S., covers use of the injectable drug as an add-on maintenance treatment for patients whose COPD is uncontrolled by available therapies. ...
- Source: drugdu
- 87
- July 9, 2024
EMA approval of Sanofi/Regeneron’s Dupixent fills biologic gap in COPD

Following the European Medicines Agency (EMA) approval of Sanofi/Regeneron’s Dupixent (Dupilumab) on July, 03 2024, Asiyah Nawab, Pharma Analyst at GlobalData, offers her view: “Dupixent, a monoclonal antibody (mAb) targeting interleukin-4 (IL4) and interleukin-13 (IL13) pathways, has been approved by the EMA as the first biologic for uncontrolled chronic obstructive pulmonary disease (COPD) patients. It is to be used specifically as an add-on maintenance treatment, given alongside the standard of care (SoC), with a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA. The approval is set to improve the treatment landscape for COPD and offer patients a treatment option with potential to improve quality of life,” states Nawab “After reviewing the data published from Sanofi/Regeneron’s two landmark phase 3 studies (BOREAS and NOTUS), Dupixent (dupilumab) was able to significantly reduce moderate or ...
- Source: drugdu
- 107
- July 6, 2024
Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy

The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is an inhaled dual inhibitor of phosphodiesterase 3 and phosphodiesterase 4 enzymes and has bronchodilator and non-steroidal anti-inflammatory effects. Verona plans to launch the therapy in Q3 this year. “With substantial funding of up to $650m secured, Verona Pharma is well-positioned to distribute Ohtuvayre in the US, ensuring its availability even beyond 2026,” said Asiyah Nawab, Pharma Analyst at GlobalData. The Ohtuvayre approval was based on the positive results from Phase III ENHANCE-1 and ENHANCE-2 trials (NCT04535986 and NCT04542057). The data from the pooled analysis of the studies showed significant improvements in the symptoms of COPD exacerbations, including dyspnea, breathlessness, cough, sputum, and chest symptoms, in patients with moderate to severe COPD. Ohtuvayre is expected to generate global sales of $1.1bn by 2029, ...
- Source: drugdu
- 86
- June 29, 2024
Amgen and AstraZeneca ponder label expansion for Tezspire in COPD

Amgen and AstraZeneca have highlighted the potential of Tezspire (tezepelumab) in chronic obstructive pulmonary disease (COPD) in a subgroup of patients in a Phase IIb study even though the trial missed the primary endpoint. The therapy failed to show a significant reduction in the annual rate of moderate to severe exacerbations compared to the placebo, the trial’s primary endpoint. The data from the placebo-controlled Phase IIa COURSE trial (NCT04039113) was presented at the American Thoracic Society (ATS) International Conference taking place in San Diego, US, from 16 to 21 May. However, a pre-determined subgroup analysis of COPD patients based on the levels of eosinophils, measured as baseline eosinophil count (BEC), showed significant reductions in COPD exacerbations. The therapy also demonstrated a 48% reduction in severe exacerbations compared to the placebo. Patients who received Tezspire while having a BEC of 150 cells/μL or more, which is associated with increased COPD-related emergency ...
- Source: drugdu
- 71
- May 22, 2024
Dupixent® Receives Another FDA Priority Review for Chronic Obstructive Pulmonary Disease (COPD) with Type 2 Inflammation

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 ...
- Source: drugdu
- 176
- February 27, 2024
Phase 3 Clinical Trial for Dupixent Reports Significant Reduced COPD Exacerbations

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 ...
- Source: drugdu
- 108
- November 29, 2023
Children exposed to second hand smoke show higher COPD mortality

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, ...
- Source: drugdu
- 1,360
- September 13, 2018
Asthma + COPD = ACOS

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.
- Source: Reuters
- 1,027
- August 24, 2018
ACOs asthma Asthma and COPD Overlap Syndrome COPD Researches
Enquiry for Nucala in COPD

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).
- Source: BioPharmaDive
- 773
- July 26, 2018
COPD GSK New Approvals

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