Clinical Scorecard: FDA Clears Breztri for Asthma Use

At a Glance

Key Highlights

• Approved for maintenance treatment of asthma in patients aged 12 years and older
• Demonstrated improved lung function compared with inhaled corticosteroid/long-acting beta2-agonist therapy in Phase 3 KALOS and LOGOS trials
• Rapid onset of action with lung function improvements within 5 minutes of initial dose

Guideline-Based Recommendations

Diagnosis

• Asthma diagnosis based on clinical presentation including symptoms such as wheezing, dyspnea, chest tightness, and exacerbations

Management

• Use Breztri (budesonide/glycopyrrolate/formoterol fumarate) as maintenance therapy for asthma patients aged 12 years and older
• Not intended for relief of acute bronchospasm or as a substitute for rescue inhalers

Monitoring & Follow-up

• Monitor lung function improvements over 12 to 24 weeks
• Assess for asthma control and exacerbation frequency

Risks

• No new safety or tolerability concerns identified in clinical trials

Patient & Prescribing Data

Approximately 4,300 randomized asthma patients aged 12 years and older, including those with and without recent exacerbations

Improved forced expiratory volume in 1 second and trough lung function compared to dual therapy; rapid onset of action; suitable for maintenance but not acute symptom relief

Clinical Best Practices

• Incorporate triple-combination inhaled therapy for patients inadequately controlled on dual maintenance therapy
• Continue to use rescue inhalers for acute bronchospasm
• Educate patients on the role of maintenance therapy versus rescue treatment
• Regularly assess lung function and symptom control to guide therapy adjustments

Related Resources & Content

• AstraZeneca FDA Approval Announcement