Designed to Address Unmet Needs in CF Patients with Pseudomonas Aeruginosa Lung Infections
- 70,000 CF patients worldwide1 (30,000 in the US2 and 35,000 in Europe3)
- CF patient life expectancy is 37 years2
- 70% of adult CF patients have chronic infections due to Pseudomonas2
- Mucus buildup impairs lung function
- Lung infections degrade lung function 1% to 3% each year4
- Current treatment is life-interrupting: approximately 15 to 20 minutes of inhalation session per dose for a total of approximately 30 to 40 minutes per day
- Inhaled antibiotic treatment is challenged by barriers to bacteria
Resources for Patients
Current treatment options vs. proprietary formulation and delivery system of ARIKACE*
*Administered once daily using an optimized eFlow® Electronic Nebulizer (PARI Pharma GmbH)
Clinical and Regulatory Status
A European and Canadian phase 3 CLEAR-108 study for CF patients with Pseudomonas lung infections initiated in the second quarter of 2012. We have recently reported top line results from the Phase 3 CF-related Pseudomonas lung infection trial and are conducting a Phase 2b trial for NTM lung infections. Learn more about this clinical trial.
Results from a clinical trial in CF patients – full results available here.
Orphan Drug Status
ARIKACE has been granted Orphan Drug status in both the US and European Union for Pseudomonas lung infections in CF patients.
1 Cystic Fibrosis Foundation website: www.cff.org/AboutCF.
2 Cystic Fibrosis Foundation Patient Registry, 2011.
3 Hoiby BMC Medicine, 2011, 9:32.
4 Liou et al, Journal of Cystic Fibrosis 9 (2010) 250-256.