Respiratory - September 2020

Respiratory - September 2020

Breztri Aerosphere approved in the US for the maintenance treatment of COPD

24 Jul 2020

Breztri Aerosphere (Budesonide/glycopyrrolate/formoterol fumarate, ICS/LAMA/LABA) – AstraZeneca

  • Now approved in the US for maintenance treatment of patients with Chronic obstructive pulmonary disease (COPD)
  • The approval was based on positive results from the Phase 3 ETHOS trial in which Breztri Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate)
  • The approval was also supported by efficacy and safety data from the Phase 3 KRONOS trial

AstraZeneca achieves milestones for Breztri, Fasenra and launches ‘Break over-reliance’ campaign for SABA inhaler

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CI Scientists Remarks: 

  • ETHOS and KRONOS are part of AstraZeneca’s ATHENA Phase 3 clinical trial program for Breztri Aerosphere, which included more than 15,500 patients globally across 11 trials
  • Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a single-inhaler, fixed dose triple-combination of budesonide, an inhaled corticosteroid (ICS), with glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA), delivered in a pressurized metered-dose inhaler

– Dr. Kowndinya, CI Scientists

For full story click here

Fasenra Phase 3b ANDHI study significantly suppressed Asthma exacerbation rate in patients with severe eosinophilic Asthma

18 Aug 2020

Fasenra (Benralizumab, Anti-IL-5Rα mAb) – AstraZeneca

  • In Phase 3b ANDHI trial, Fasenra when given on top of standard of care, demonstrated a statistically significant 49% reduction in the annual rate of Asthma exacerbations at week 24 compared to placebo (0.94 vs. 1.86; p≤0.0001) in patients with baseline blood eosinophil counts greater than or equal to 150 cells per microliter
  • In key secondary endpoints, Fasenra demonstrated a statistically significant and clinically meaningful improvement in health-related quality of life at week 24 compared to placebo (p≤0.0001), with similar differences seen at all earlier time points, as measured by the St. George’s Respiratory Questionnaire (SGRQ)
  • Fasenra also demonstrated early improvements in lung function, as measured by forced expiratory volume in one second (FEV1) of up to 160ml at week 24, compared to placebo (p<0.0001), as well as improvements in Asthma control (p≤0.001), as measured by the Asthma Control Questionnaire 6 (ACQ-6)
  • In a subgroup of patients with Chronic rhinosinusitis with nasal polyposis (NP) at baseline, Fasenra demonstrated a clinically relevant improvement in symptoms at week 24 compared to placebo (p=0.0204), with similar differences seen at all earlier time points, as measured by the Sino-Nasal Outcome Test (SNOT-22)

CI Scientists Remarks: 

  • ANDHI is a Phase 3b, randomized, double-blind study to evaluate the safety and efficacy of subcutaneous Fasenra 30 mg for placebo in 24 weeks in patients with uncontrolled severe Asthma who are being treated with standard treatment
  • Fasenra is the key growth driver for AstraZeneca in Q2’20 with sales growth of 31% in US, 102% in EU and 20% in rest of the world

– Dr. Kowndinya, CI Scientists

For full story click here

GAAPP and AstraZeneca launch campaign to help Asthma patients break over-reliance on their SABA 'blue' reliever inhaler to prevent Asthma attacks

01 Sep 2020

‘Break Over-Reliance’ campaign – AstraZeneca

  • Global Allergy and Airways Patient Platform (GAAPP) and its member organizations are partnering with AstraZeneca to launch a global public health awareness campaign to educate Asthma patients on the risks associated with over-reliance on short-acting beta2 agonist (SABA) ‘blue’ reliever inhalers
  • Evidence shows that over-reliance on reliever inhalers for symptom management – defined as using this type of inhaler three or more times a week – is an indicator of increased risk of Asthma attacks
  • The ‘Break Over-Reliance’ campaign is launching internationally in Sep’20
  • At the heart of the campaign is an educational website featuring information that helps patients to take action, supports healthcare professionals to conduct ongoing treatment reviews, and encourages policymakers to identify mechanisms of change at the policy level to improve national standards of Asthma management
  • The campaign provides an evidence-based digital tool, the Reliever Reliance Test at www.rateyourreliance.com, to assess a patient’s reliance on their SABA
  • The five-item questionnaire is adapted from the validated SABA Risk Questionnaire. The first-of-its-kind patient-friendly tool is aimed at helping patients have relevant consultations with health professionals about how to best control their Asthma

CI Scientists Remarks: 

  • The new GINA 2020 Asthma treatment guidelines note that SABA overuse is associated with an increased risk of severe Asthma attacks, and state that low-dose inhaled steroid plus formoterol is now the preferred reliever across Asthma severities for patients who are prescribed maintenance and reliever therapy creating a new gap that can be filled by ICS-LABA combination
  • Break Over-Reliance campaign will help AstraZenca to identify patients with over-reliance on SABA reliever and shift them to their ICS-LABA combination drug, SYMBICORT

– Dr. Kowndinya, CI Scientists

For full story click here

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