COPD

Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation

Retrieved on: 
пятница, мая 31, 2024
Patient, Food, FDA, Safety, Regeneron Pharmaceuticals, EMA, COPD, Chronic obstructive pulmonary disease, Committee, European, CHMP, Pharmaceutical industry

The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.

Key Points: 
  • The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
  • The FDA had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials.
  • Additionally, submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including the European Union (EU) and China.
  • The potential use of Dupixent in COPD is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD

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пятница, мая 31, 2024
Patient, Headache, Diarrhea, Risk, Cough, COVID-19, Priority, Respiratory disease, Smoking, Food, Depression, FDA, Anxiety, Disease, Safety, Health, Mucus, Common, Hospital, Death, European Commission, COPD, Back pain, Chronic obstructive pulmonary disease, Regeneron Pharmaceuticals, Priority review, European, CHMP, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent® (dupilumab) in the European Union (EU) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • COPD is a respiratory disease that damages the lungs and causes progressive lung function decline, and is the fourth leading cause of death worldwide.
  • COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalization.
  • The use of Dupixent in COPD is investigational and is not yet approved by global regulatory authorities.

Press Release: Dupixent recommended for EU approval by the CHMP to treat patients with COPD

Retrieved on: 
пятница, мая 31, 2024
Patient, Headache, Diarrhea, Risk, Cough, COVID-19, Priority, Respiratory disease, Smoking, Food, Depression, FDA, Anxiety, Disease, Safety, Health, Mucus, Common, Hospital, Death, European Commission, COPD, Back pain, Chronic obstructive pulmonary disease, Priority review, European, CHMP

The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

Key Points: 
  • The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
  • COPD is a respiratory disease that damages the lungs and causes progressive lung function decline and is the fourth leading cause of death worldwide.
  • Safety results in both studies were generally consistent with the known safety profile of Dupixent in its approved indications.
  • The use of Dupixent in COPD is investigational and is not yet approved by global regulatory authorities.

Press Release: Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation

Retrieved on: 
пятница, мая 31, 2024
Sanofi, Patient, Food, FDA, Safety, Regeneron Pharmaceuticals, EMA, COPD, Chronic obstructive pulmonary disease, Committee, European, CHMP, Pharmaceutical industry

The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.

Key Points: 
  • The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
  • The FDA had requested additional efficacy analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials.
  • Sanofi and Regeneron are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.
  • Additionally, submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including the European Union and China.

Apogee Therapeutics Expands Board of Directors with the Appointment of Lisa Bollinger, MD

Retrieved on: 
вторник, мая 28, 2024
CDER, Research and development, Hospital, Amgen, Food, Drug development, Pediatrics, University, Atopic dermatitis, FDA, Therapy, Safety, Book, SAN, Publication, Asthma, I&I, MD, Outline of health sciences, Regulatory affairs, COPD, Division, Chronic obstructive pulmonary disease, Research, Physiology

Dr. Bollinger’s over 30 years of experience in drug development, with deep regulatory experience gained both within the U.S. FDA and multinational biotechnology and pharmaceutical companies contributed to the Apogee board of directors’ selection decision.

Key Points: 
  • Dr. Bollinger’s over 30 years of experience in drug development, with deep regulatory experience gained both within the U.S. FDA and multinational biotechnology and pharmaceutical companies contributed to the Apogee board of directors’ selection decision.
  • “With extensive experience in the pharmaceutical and regulatory industries, coupled with her background as a practicing pediatric physician, Lisa brings an impressive skill set to our board of directors,” said Michael Henderson, MD, Chief Executive Officer of Apogee.
  • “We have several exciting milestones ahead at Apogee in 2024 with two programs now in clinical development and a third expected in the second half of the year.
  • I am excited to partner with this exceptional team and board of directors to advance programs that I strongly believe could offer a number of advantages over today’s standard of care options.”

FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs

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вторник, мая 28, 2024
Semaglutide, GSK plc, Diabetes, The Orange Book, Commission, Patent, Food, Orange Book, Novartis, Federal Trade Commission, Obesity, Investment, FDA, Asthma, Boehringer Ingelheim, Plasma protein binding, Hypoglycemia, Policy, COPD, Weight loss, Novo Nordisk, Ciclosporin, AstraZeneca, FTC

These patent listings are currently listed in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, which lists drug products approved by the FDA as safe and effective.To promote competition, the FTC said it is disputing these patent listings as improper or inaccurate.

Key Points: 
  • These patent listings are currently listed in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, which lists drug products approved by the FDA as safe and effective.

    To promote competition, the FTC said it is disputing these patent listings as improper or inaccurate.

  • Improper Orange Book patent listings can delay cheaper generic alternatives from entering the market, keeping brand name drug prices artificially high.

    “By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” said FTC Chair Lina M. Khan.

  • The Commission’s November challenges led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisting patents in response to the FTC’s warning letters.
  • According to the policy statement, costs associated with challenging improperly listed patents can disincentivize investments in developing generic drugs, which risks delaying or thwarting competitive generic alternatives.

Developed in Collaboration with Leading Scientists, New ResMed-Supported Research at ATS 2024 Provides Evidence of the Effectiveness and Critical Role of Positive Airway Pressure Therapy

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четверг, мая 23, 2024
Risk, Obesity, ESS, ResMed, Ageing, SAN, ATS, Woman, ASV, Therapy, University of California, ASX, Plan, Health care, LVEF, Coronary artery disease, Sleep, Grenoble Alpes University, Literature review, Natural language processing, Conference, CSA, Circulatory system, Meta-analysis, BMI, AHI, Clinical trial, NIV, Obstructive sleep apnea, Qualitative Research (journal), Comorbidity, Depression, NYHA, Sleep disorder, Hospital, Research, OSA, COPD, Central sleep apnea, PAP, Patient, Education, Qualitative, RMD, Prevalence, University, Overalls, Mortality, Death, Abstract, Economy, Adaptation, Quality of life, Pharmaceutical industry

SAN DIEGO, May 23, 2024 (GLOBE NEWSWIRE) -- A number of accomplished medical and scientific experts presented critical new research on sleep conditions and their effect on cardiovascular health at the American Thoracic Society International Conference. The ResMed-supported research provided new insights into the effectiveness of PAP therapy in treating sleep-disordered breathing and its associated clinical benefits. The studies were among 26 supported by ResMed (NYSE: RMD, ASX: RMD) in collaboration with leading scientists including Michael Arzt, MD, Universitätsklinikum Regensburg, Germany; Jean-Louis Pépin, MD, Grenoble Alpes University, France; Atul Malhotra, MD, University of California, San Diego; and Holger Woehrle, Ulm Lung Centre, Germany.

Key Points: 
  • The ResMed-supported research provided new insights into the effectiveness of PAP therapy in treating sleep-disordered breathing and its associated clinical benefits.
  • Several studies demonstrated findings showing continued effectiveness of PAP therapies for patients with sleep disorder conditions like obstructive sleep apnea.
  • This finding demonstrates a correlation between the use of PAP therapy and a reduction in use of healthcare resources.
  • Two studies evaluated the effects of Adaptive Servo-Ventilation (ASV) therapy in two populations, patients with TE-CSA and patients on long-term opioid therapy.

Apogee Therapeutics to Participate in Upcoming June Investor Conferences

Retrieved on: 
четверг, мая 23, 2024
News, Atopic dermatitis, Therapy, Asthma, SAN, COPD, Apsis

SAN FRANCISCO and WALTHAM, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, COPD, asthma and other inflammatory and immunology indications, today announced that members of management will participate at the following upcoming investor conferences:

Key Points: 
  • SAN FRANCISCO and WALTHAM, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, COPD, asthma and other inflammatory and immunology indications, today announced that members of management will participate at the following upcoming investor conferences:
    A live and archived webcast of the fireside chat and presentation will be available via the News & Events page in the Investors section of the Apogee Therapeutics website.

Pneumagen Presents Positive Phase 2 Influenza Human Challenge Study data on Neumifil, its Broad-Spectrum Antiviral Drug, at the American Thoracic Society (ATS) 2024 Conference

Retrieved on: 
четверг, мая 23, 2024
Patient, Viral, Control, American Thoracic Society, Incidence, COPD, CHIM, ATS, Chronic obstructive pulmonary disease, Viral load, Clinical trial, Infection, Vaccine

These data were featured during an oral presentation* at the American Thoracic Society (ATS) in San Diego on 21st May.

Key Points: 
  • These data were featured during an oral presentation* at the American Thoracic Society (ATS) in San Diego on 21st May.
  • The presentation, entitled “HEX17, a Novel Broad-spectrum Antiviral Intranasal Drug, Demonstrates Efficacy Against Influenza in a Controlled Human Infection Model Conducted in Healthy Adults,” was delivered by Dr Geoff Kitson, Chief Medical Officer of Pneumagen.
  • “We are very pleased to present detailed data from our Phase 2 Clinical trial of Neumifil,” said Douglas Thomson, Chief Executive Officer of Pneumagen.
  • The significant reductions in both symptoms and viral load, demonstrate the potential of this new antiviral drug not only to alleviate patients suffering but also to curtail the spread of virus within communities.

ASLAN Pharmaceuticals Presents Late-Breaking Translational Data on Eblasakimab in COPD at the American Thoracic Society International Conference

Retrieved on: 
вторник, мая 21, 2024
Patient, Female, Dupilumab, Male, ASLN, SAN, Eosinophilic bronchitis, Asthma, Conference, American Thoracic Society, Bronchoconstriction, Interleukin 4, Publication, COPD, ATS, Poster, Airway obstruction, Inflammation, History, Pharmaceutical industry

“We are pleased to present the translational data that we have generated on eblasakimab in COPD at this prestigious conference.

Key Points: 
  • “We are pleased to present the translational data that we have generated on eblasakimab in COPD at this prestigious conference.
  • Since airway hyperresponsiveness is clinically shared across asthma, COPD, and other lung disorders, these data support the further investigation of eblasakimab in a range of Type 2-driven lung conditions,” said Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals.
  • ATS 2024 International Conference presentation details:
    Type 2 inflammation is observed in 30-40% of COPD patients1 and during exacerbations, characterized by impaired airflow, obstruction, and dyspnea2.
  • This suggests that eblasakimab may potentially provide stronger relief against bronchoconstriction as well as improved dilatory function in COPD compared to dupilumab.