The FDA is reviewing Insmed’s application for ARIKAYCE (inhaled liposomal amikacin) and the FDA needs to hear from you now. Please consider writing to the FDA to let them know why it’s so important that we finally have this approved therapy. The review deadline set by the FDA is September 28th. We do not know at this time whether the date will be extended, so please send your letter as soon as possible.
Below are some key points to incorporate in your message, and you can click here for a brief background on the advisory committee meeting. You can email your letter directly to the FDA using the instructions below.
How to send your letter
Dr. Janet Woodcock
Director, Center for Drug Evaluation and Research
Acting Director, Office of New Drugs
U.S. Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993
Dear Dr. Woodcock,
As a patient with NTM lung disease I respectfully submit the attached letter for your consideration. I appreciate your time and consideration of the patient perspective in your decision making.