Posted on February 01, 2018 |
Aradigm, the company that submitted Linhaliq to the FDA for approval, announced that they had received a complete response letter from the FDA stating that they would not approve the treatment at this time.
Over the last several months many of you have communicated with the FDA about the unmet need in the Bronchiectasis community. You told them your priorities, your needs and your frequent battles to keep exacerbations at bay.
While we are disappointed that important patient focused issues were not adequately addressed within the FDA’s response to Aradigm, we believe that your voices will make a difference in moving forward in the quest to identify and approve new treatments for bronchiectasis. We appreciate Aradigm’s commitment to addressing the needs of the bronchiectasis community and will continue to work with all stakeholders to improve the lives of people with bronchiectasis moving forward.
If you would like to read more about Aradigm’s announcement you can view the press release here.