FDA to Review Elexacaftor, Tezacaftor, Ivacaftor Combination for Cystic Fibrosis
The FDA has accepted for priority review the NDA for elexacaftor, tezacaftor and ivacaftor triple combination regimen for patients with cystic fibrosis.
Obstructive Lung Disease
Novel Triple Combination Therapy for Cystic Fibrosis Submitted for FDA Review
The NDA for the investigational therapy elexacaftor (VX-445), for use in combination with tezacaftor and ivacaftor in the treatment of cystic fibrosis, has been submitted to the FDA.
Key Cystic Fibrosis Pathogens Reduced With Ivacaftor
Ivacaftor use was linked to reductions in P. aeruginosa rates, prevalence of S. aureus, Aspergillus species.
Palivizumab Not Associated With Improved Long-Term Outcomes in Cystic Fibrosis
Treatment with palivizumab was not associated with improved long-term outcomes in children with cystic fibrosis.
Ivacaftor Safe in Cystic Fibrosis With Non-G551D Gating Mutations
Ivacaftor is safe and effective in patients with cystic fibrosis who have severe lung disease and non-G551D gating mutations.
Azithromycin in Cystic Fibrosis Offers Short-Term Lung Function Improvements
Treatment with azithromycin is associated with short-term, but not long-term, changes in lung function in children with cystic fibrosis.
Inhaled Gallium Citrate Gets Orphan Drug Designation for Treating Lung Infection in Cystic Fibrosis
The FDA has granted Orphan Drug designation to AR-501, an investigational treatment for chronic bacterial lung infections in patients with cystic fibrosis.
Ibuprofen and Antibiotics Display Synergy Against Pseudomonas aeruginosa
Combinations of ibuprofen with aztreonam and ceftazidime display synergistic antimicrobial activity against drug-resistant Pseudomonas aeruginosa isolates in vitro.
Tezacaftor/Ivacaftor and Ivacaftor Approved for Younger Patients With Cystic Fibrosis
The FDA has approved Symdeko for the treatment of patients aged ≥6 years with cystic fibrosis.
Invasive Mechanical Ventilation May Improve Cystic Fibrosis Mortality Rates
Patients with cystic fibrosis who undergo invasive mechanical ventilation may have a lower risk for in-hospital mortality.
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