Global Initiative for Asthma

AIRSUPRA® (albuterol/budesonide) now available as the first and only FDA-approved anti-inflammatory rescue option for asthma

Retrieved on: 
Monday, January 22, 2024
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In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma.

Key Points: 
  • In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma.
  • In DENALI, AIRSUPRA had a similar onset of bronchodilation compared to albuterol in patients with mild to moderate asthma.2
    The approach to treating asthma symptoms with rescue has changed.
  • The 2023 Global Initiative for Asthma (GINA) report supports a rescue approach that treats both symptoms and inflammation together.
  • Now, with AIRSUPRA available we can provide patients, especially those on maintenance therapy, another rescue option for managing their breakthrough symptoms.

PT027 Recommended by FDA Advisory Committee as New Rescue Treatment for Asthma

Retrieved on: 
Wednesday, November 9, 2022
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PT027 is a potential first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed.

Key Points: 
  • PT027 is a potential first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed.
  • In March 2018, AstraZeneca and Avillion signed an agreement to advance PT027 through a global clinical development program for the treatment of asthma.
  • Following the successful approval of PT027, AstraZeneca has the option, upon certain financial payments, to commercialize the medicine in the US.
  • The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death.

US FDA accepts New Drug Application filed by Avillion for AstraZeneca's PT027 for the as-needed treatment or prevention of symptoms in asthma patients

Retrieved on: 
Tuesday, May 31, 2022
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The proposed indication is for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.

Key Points: 
  • The proposed indication is for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.
  • Under the terms of the agreement, Avillion funded, sponsored, and executed a multicentre, global clinical trial programme for PT027 comprising four studies involving more than 4,000 patients.
  • Following the successful approval of PT027, AstraZeneca has the option, upon certain financial payments, to commercialise the medicine in the US.
  • The NDA submission is based on data from studies conducted by AstraZeneca and Avillion to assess the safety and efficacy of PT027.

US FDA accepts New Drug Application filed by Avillion for AstraZeneca's PT027 for the as-needed treatment or prevention of symptoms in asthma patients

Retrieved on: 
Tuesday, May 31, 2022
Inflammation, Risk, Budesonide, Medicine, Kidney, Food, US Foods, Cataract, International Conference on Nuclear Disarmament, Oslo, 2008, Asthma, International, Global Initiative for Asthma, Salbutamol, New Drug Application, Patient, File, Health, Treatment, American Thoracic Society, The New England Journal of Medicine, Pneumonia, SABA, Global Initiative, Thakeham, FDA, Bronchoconstriction, Partnership, ICS, Time, ATS, Conference, Safety, Wheeze, NDA, Drug development, Breathe Me, Depressive anxiety, OCS, MD, Cardiovascular disease, AstraZeneca, Pharmaceutical industry

The proposed indication is for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.

Key Points: 
  • The proposed indication is for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.
  • Under the terms of the agreement, Avillion funded, sponsored, and executed a multicentre, global clinical trial programme for PT027 comprising four studies involving more than 4,000 patients.
  • Following the successful approval of PT027, AstraZeneca has the option, upon certain financial payments, to commercialise the medicine in the US.
  • The NDA submission is based on data from studies conducted by AstraZeneca and Avillion to assess the safety and efficacy of PT027.

PT027, a Novel Fixed-Dose Combination of Albuterol and Budesonide, Used as an As-Needed Rescue Medicine, Significantly Reduced the Risk of a Severe Exacerbation Compared to Albuterol by 27% in Patients With Asthma

Retrieved on: 
Sunday, May 15, 2022
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PT027 is a potential first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed.

Key Points: 
  • PT027 is a potential first-in-class SABA/ICS rescue treatment for asthma in the US, to be taken as needed.
  • AstraZenecas ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.
  • Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.
  • The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK.

DGAP-News: sterna biologicals announces dosing of first patient in phase IIa proof-of-concept study with SB010 in moderate to severe asthma

Retrieved on: 
Monday, December 20, 2021
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"We are pleased that the first patient has been treated in our GIANT-1 trial with inhaled SB010 in patients with uncontrolled moderate to severe asthma," said Dr. Marion Wencker, Chief Medical Officer of sterna biologicals.

Key Points: 
  • "We are pleased that the first patient has been treated in our GIANT-1 trial with inhaled SB010 in patients with uncontrolled moderate to severe asthma," said Dr. Marion Wencker, Chief Medical Officer of sterna biologicals.
  • "I am excited about the potential SB010 holds in treating patients with moderate to severe uncontrolled asthma.
  • In this study, sterna will for the first time, combine pharmacological and digital therapy by integrating VisionHealth's Kata(R) Clinical into the trial.
  • Consequently, the Company's therapeutic candidates containing hgd40, SB010 and SB012, address several inflammatory processes simultaneously and rebalance an overall dysregulated immune response.

Fixed-Dose Combination of Albuterol and Budesonide (PT027) Demonstrated Significant Benefits for Asthma Patients in MANDALA and DENALI Phase III Trials

Retrieved on: 
Thursday, September 9, 2021
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The trial included 3,132 patients with moderate to severe asthma taking maintenance ICS with or without additional controller medicines.

Key Points: 
  • The trial included 3,132 patients with moderate to severe asthma taking maintenance ICS with or without additional controller medicines.
  • Inflammation is a distinctive feature of asthma and plays a key role in asthma symptoms, exacerbations and deaths.
  • Many millions of patients globally rely on their rescue inhaler to alleviate acute symptoms, but this does not treat the underlying inflammation in asthma.
  • The MANDALA and DENALI trials demonstrate an albuterol/budesonide rescue inhaler can address inflammation and prevent exacerbations, making PT027 an important potential new treatment option for patients.