The Fast Track designation is intended to expedite the review of new drugs that have the potential to serve unmet medical needs in serious or life-threatening conditions. Under this designation Insmed will have the opportunity to submit completed sections of any future NTM New Drug Application (NDA) for rolling review by FDA, rather than waiting until every section of the application is complete before the entire application can be reviewed. FDA’s review clock for the NDA will begin once the final section is submitted.“QIDP designation for ARIKACE underscores the importance the FDA places on helping to advance critically needed antibiotics for serious infections such as NTM,” stated Mr. Lewis. “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.”
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
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