Insmed announced positive developments in both of its clinical development programs for Arikace (liposomal amikacin for inhalation), an inhaled anti-infective to treat patients battling serious lung diseases. The FDA has also granted Arikace a Qualified Infectious Disease Product (QIDP) and Fast Track designation for the treatment of Non-Tuberculous Mycobacteria (NTM) lung infections.
The Phase 3 trial was an open-label, multi-center, randomized study designed to assess the safety and efficacy of Arikcase vs. TOBI (tobramycin inhalation solution) in cystic fibrosis patients with Pseudomonas aeruginosa. Adult and pediatric cystic fibrosis patients (n=302) with chronic Pseudomonas aeruginosa were randomized to receive 28-days of Arikace treatment delivered once-daily via an investigational eFlow Nebulizer System, or TOBI delivered twice-daily via the PARI LC Plus Nebulizer System over a 24-week treatment period. About 75% of eligible patients from this Phase 3 trial consented to participate in a two-year, open-label safety extension study. The primary endpoint was relative change in FEV1 measured after three treatment cycles, with each cycle consisting of 28 days “on” treatment and 28 days “off” treatment.
The primary endpoint of once-daily Arikace to treat Pseudomonas aeruginosa in cystic fibrosis was met of non-inferiority compared with twice-daily TOBI for relative change in forced expiratory volume in one second (FEV1), measured at the end of the third treatment cycle (24 weeks) as compared to baseline.
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