FDA Approval Date of Arnuity (Fluticasone Furoate)
Arnuity (fluticasone furoate) was approved by the FDA in 2014 as a once-daily inhaled corticosteroid for asthma management. 1
Background on Arnuity
Arnuity is a novel inhaled corticosteroid (ICS) with 24-hour activity that was developed as a once-daily treatment option for asthma management. It contains the active ingredient fluticasone furoate (FF), which differs from the more commonly known fluticasone propionate.
Key Features of Arnuity:
- Dosing Schedule: Once-daily dosing, which offers potential adherence advantages compared to twice-daily ICS medications 2
- Delivery System: Administered via a dry powder inhaler
- Age Indications: Initially approved for patients 12 years and older, with later expansion to include younger patients
Clinical Evidence Supporting Approval
Multiple clinical trials demonstrated the efficacy of fluticasone furoate prior to its approval:
- Studies showed that FF at total daily doses of 200 mcg or 400 mcg was significantly more effective than placebo in improving lung function 2
- FF 400 mcg once daily in the evening demonstrated similar efficacy to FF 200 mcg twice daily, supporting the once-daily dosing regimen 2
- In patients previously uncontrolled on low-dose ICS, FF 100-400 mcg once daily provided significant improvements in pre-dose FEV1 compared to placebo 3
- The absence of a dose-response relationship across FF doses in moderate persistent asthma suggested that 200 mcg was an appropriate dose for this population 4
Subsequent Developments
Following the initial approval of Arnuity as a standalone product, fluticasone furoate was also developed in combination with vilanterol (a long-acting β2-agonist) as a once-daily maintenance treatment for both asthma and COPD:
- The combination (FF/VI) was shown to reduce the risk of severe asthma exacerbations compared to FF alone 5
- FF/VI demonstrated improvements in lung function with good tolerability in adolescents and adults with asthma 5
- For COPD management, FF/VI showed benefits, though with an increased risk of pneumonia compared to vilanterol alone 6
Clinical Implications
When considering Arnuity for asthma management:
- The once-daily dosing may improve treatment adherence compared to twice-daily regimens
- Proper administration technique and use of spacers when appropriate can help minimize local side effects
- Monitoring for potential systemic effects is important, particularly at higher doses
- As with all ICS medications, the lowest effective dose should be used to maintain asthma control
Common Side Effects
- Local effects include cough, dysphonia (voice changes), and oral thrush 7
- Systemic effects at higher doses may include adrenal suppression and potential growth effects in pediatric patients 7
The approval of Arnuity represented an important addition to the asthma treatment armamentarium, offering the convenience of once-daily dosing while maintaining efficacy comparable to established twice-daily ICS options.