The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the second RTF letter issued by the FDA this week, the first to Acorda Therapeutics on Tuesday.
SteadyMed submitted its application to the FDA in June, but the federal watchdog has requested more information on certain device specifications and performance testing, as well as additional design verification and validation testing.
The company said it plans to request a meeting with the FDA to better understand what it needs to resubmit its application.
“We believe that the issues raised in the letter from FDA can be sufficiently addressed. Our next step is to work with the FDA to address the open issues and identify a path to a successful resubmission and acceptance of our application,” president & CEO Jonathan Rigby said in prepared remarks. “We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and remain committed to bringing the product to patients in need.”