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.”
Pursuant to QIDP status, the Company expects to continue its dialogue with the FDA regarding the regulatory pathway for registration and approval of ARIKACE to treat NTM. Insmed expects to complete the Phase 2 data review and related dialogue with the FDA by the end of the first quarter of 2014.
Conference Call and WebcastInsmed management will host an investment community conference call today at 8:00 a.m. Eastern time, featuring several experts in the fields of CF and NTM. Shareholders and other interested parties may participate in the call by dialing 888-803-5993 (domestic) or 706-634-5454 (international) and referencing conference ID number 13711485. Slides containing data from the Phase 3 ARIKACE trial will be posted at 7:15 a.m. Eastern time on July 1, 2013 on the homepage of the Company’s website at www.insmed.com. The call will also be webcast live and archived on the Company’s website at http://investor.insmed.com/events.cfm. A replay of the conference call will be accessible two hours after its completion through July 15, 2013 by dialing 855-859-2056 (domestic) or 404-537-3406 (international) and referencing conference ID number 13711485. The call will also be archived for 90 days on the Company’s website at www.insmed.com. About Cystic Fibrosis According to the Cystic Fibrosis Foundation, CF is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the U.S. (70,000 worldwide). A defective gene and its protein product cause the body to produce unusually thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections, and obstructs the pancreas and stops natural enzymes from helping the body break down and absorb food.