Aradigm, the company that submitted Linhaliq to the FDA for approval, announced that they had received a complete response letter (CRL) from the FDA stating that they would not approve the treatment at this time.
Many of you have communicated recently with the FDA about the unmet needs for bronchiectasis patients. 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. As we mobilize to address this and other decisions by the FDA, we will keep you apprised so you may add your voices to those actions as well.
We appreciate Aradigm’s commitment to addressing the needs of the NTM and bronchiectasis communities and will continue to work with all stakeholders to improve the lives of people with NTM and bronchiectasis. We urge you to read more about Aradigm’s announcement by viewing their press release here.