Upcoming FDA Advisory Committee Meeting for ALIS
Posted on July 12, 2018 |
The U.S. Food & Drug Administration (FDA) has posted a Federal Register Notice announcing the upcoming Anti-Microbial Advisory Committee Meeting for Insmed’s inhaled liposomal amikacin. The committee will discuss new drug application (NDA) 207356, amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen.
The meeting will take place on August 7, 2018 in the Great Room at the FDA’s White Oak campus (10903 New Hampshire Avenue, Silver Spring, MD).
If you are a patient with MAC lung disease who either did or did not participate in the Insmed clinical trial, and you wish to address the committee during the Open Public Hearing session of the meeting that day, please contact Amy or Susan at firstname.lastname@example.org. Please note that the deadline to register as a speaker for the FDA meeting is July 16th, so anyone who is interested should contact them as soon as possible. Compensation will be offered for travel expenses.
It would be most helpful to have two or three patients speak before the committee for 3 to 5 minutes each, addressing the severe unmet need you have as a patient, and how this drug can benefit you. If you participated in the trial, you should also discuss how it helped you, and how it would be beneficial to you to have this drug approved so they can take it.
For those unable to attend the meeting in person or who will not be speaking at the meeting, the FDA offers the opportunity to submit written comments to the docket, no later than July 24, 2018. Statements submitted are public; those submitted before the deadline are printed out and given to committee members with their briefing materials. Comments can be submitted via this link: https://www.regulations.gov/document?D=FDA-2018-N-2490-0001. Just click on the Comment Now! button.