Arikace amikacin: Extension study data

An interim DSMB review of 98 evaluable CF patients with chronic P. aeruginosa infection who completed the first year of the 2-year, open-label CLEAR-110 extension study showed that once-daily 560 mg Arikace was well tolerated and led to sustained improvement in mean FEV1 from baseline during both on- and off-treatment periods. Insmed said patients also showed a sustained reduction in density of P. aeruginosa sputum while on treatment. Each cycle consists of once-daily Arikace administered with the eFlow Nebulizer System from Pari GmbH (Starnberg, Germany) for 28 days followed by 28 days off-treatment. CLEAR-110 enrolled 206 patients who completed the European and Canadian Phase III CLEAR-108 trial.

Last year, Insmed reported data from CLEAR-108 showing Arikace met the primary endpoint of non-inferiority to twice-daily 300 mg TOBI tobramycin inhalation solution in the mean relative change from baseline in FEV1 at day 168 (p=0.4809) (see BioCentury, July 15, 2013). This half, Insmed plans to submit regulatory applications to EMA and Health Canada for Arikace to treat P. aeruginosa infection in CF patients. ...