According to Insmed, a Phase 3 study of more than 300 cystic fibrosis patients has demonstrated the non-inferiority of once-daily Arikace inhaled liposomal amikacin to twice-daily TOBI tobramycin inhalation solution, meeting the study’s primary endpoint. The company also announced that the FDA has granted Arikace Fast Track and Qualified Infectious Disease Product (QIDP) designations for the treatment of non-tuberculous mycobacteria (NTM) lung infections.
The 70-site Phase 3 study of Arikace for the treatment of P. aeruginosa infections in CF patients measured FEV1 after three 28-day treatment cycles with either Arikace or TOBI over a 24-week period. In addition to achieving the primary endpoint, secondary endpoints and the safety profile also showed Arikace to be comparable to twice-daily TOBI. Three quarters of the patients enrolled in the study have consented to take part in a 2-year extension safety study.
Insmed Executive VP Development and Chief Medical Officer Renu Gupta said, “The Phase 3 study of Arikace achieved its primary endpoint and demonstrated that Arikace is an effective inhaled antibiotic. These results are consistent with our earlier studies of Arikace and we believe further strengthen the clinical data packages Insmed is developing for submission to the EMA and Health Canada for Arikace in the treatment of CF. If approved, we believe Arikace, with its once-daily administration, represents a novel alternative for clinicians treating CF patients with chronic lung infection caused by Pseudomonas aeruginosa.”
On the FDA designations for the NTM indication, President and CEO Will Lewis commented, “QIDP designation for Arikace underscores the importance the FDA places on helping to advance critically needed antibiotics for serious infections such as NTM. We believe this is an acknowledgment by the FDA of the potentially important role that Arikace may play in the treatment of NTM. QIDP and Fast Track designations may help us bring Arikace to patients who face these serious and life-threatening lung infections more quickly. We also believe that QIDP status complements the intellectual property protection provided by our underlying patents.”
Read the Insmed press release.
