The FDA “approvable letter” is the second such setback that the company has suffered in its attempts to gain marketing approval for the drug in the US, and will constitute a further delay in the drugs path to market as the company seeks to address the concerns raised by the agency.
In its approvable letter, the agency said the clinical studies that the company submitted in its marketing application were not consistent enough to support the efficacy of the drug.
“In the approvable letter, the FDA strongly encouraged us to meet with them to discuss how best to move forward with the application. We intend to request this meeting in the near future,” stated Dr Christy Shaffer, president and CEO of Inspire. “In addition, our Joint Development Committee with Allergan will be meeting next week to discuss strategies for the program.