Data from Pharmawand - Curated by EPG Health - Date added 11 July 2018
Insmed Incorporated announced that the Division of Antimicrobial Products of the FDA has notified the company of a planned advisory committee meeting to review data supporting Insmed’s New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) (Arikayce) for adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). The tentative date for the meeting is set for August 7, 2018.
“Currently there are no approved therapies for this rare, progressive and potentially fatal disease, representing a significant unmet need,” commented Will Lewis, President and Chief Executive Officer of Insmed.
The Company has previously announced that the FDA accepted and considered the NDA for ALIS filed on May 27, 2018. The FDA granted Insmed's request for Priority Review and has set an action date of 28 September 2018 under the Prescription Drug User Fee Act (PDUFA). Priority Review applies to an application for a drug that treats a serious condition and that, if approved, would provide a significant improvement in safety or effectiveness. The FDA has previously designated ALIS as an orphan drug, a breakthrough therapy and a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act.