Most Recent Articles by Steve Duffy
The FDA has granted Orphan Drug Designation to a novel inhaled treatment that could potentially improve lung function in patients with cystic fibrosis.
Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.
Both doses will be supplied in single-dose, prefilled syringes for manual injection.
The Breakthrough designation follows an FDA examination of results from a Phase 2 randomized, double-blind trial which evaluated the safety and immunogenicity of the treatment in adults aged 60 to 64 years.
Pooled data from two identical 12-week pivotal Phase 3 trials (N=1229) in patients with moderate to very severe COPD showed that the mean annualized rate of all COPD exacerbations was 0.47, 0.45, and 0.55 for revefenacin 175mcg/day, 88mcg/day, and placebo, respectively.