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ARIKACE Meets Primary Endpoint Of Non-Inferiority To TOBI In Phase 3 Clinical Trial In Europe And Canada To Treat Pseudomonas Aeruginosa In Cystic Fibrosis Patients

Safety

During all three treatment cycles, the safety profile of ARIKACE was comparable to TOBI, with adverse events consistent with those seen in similar studies and expected in a population of CF patients receiving inhaled antibiotics. There was no difference between arms in the reporting of serious adverse events and there were no unexpected adverse events.

"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," said Renu Gupta, MD, FAAP, Executive Vice President Development and Chief Medical Officer of Insmed. “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."

“The study achieved its primary endpoint and suggests that once-daily ARIKACE treatment was comparable to twice-daily TOBI treatment, the current gold standard of care for cystic fibrosis patients with Pseudomonas aeruginosa lung infections,” stated Felix Ratjen, MD, PhD, FRCPC Head, Division of Respiratory Medicine, Sellers Chair of Cystic Fibrosis, Professor, University of Toronto Hospital for Sick Children and Co-Chair of the study Steering Committee. “These results provide hope that an inhaled aminoglycoside that requires only once-daily dosing may be added to the toolbox of available therapies for physicians to treat cystic fibrosis patients who suffer from chronic Pseudomonas aeruginosa lung infections.”

“This early review of data is encouraging. ARIKACE has the potential to be the first once-daily treatment, as compared with the current treatment regimens that require multiple dosing each day. Once-daily treatment may significantly enhance patient convenience and compliance,” stated Bonnie Ramsey, MD, Seattle Children’s Hospital, Director, Cystic Fibrosis Therapeutics, Development Network Coordinating Center and Chair of the study Steering Committee.

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