Aradigm Corp. (NSDQ:ARDM) shares tumbled today after the company reported that the FDA denied its application for an inhaled drug designed to treat non-cystic fibrosis bronchiectasis patients with chronic lung infections.
The agency’s complete response letter reportedly highlighted an array of concerns with the initial application, including product quality and the company’s clinical data.
Specifically, the FDA recommended that an independent third party verify the Phase III results that Aradigm included in the NDA. The company should also conduct an additional Phase III trial to demonstrate a significant treatment effect on the frequency and severity of exacerbations over a period of two years, the FDA said.
The CRL also requested that Aradigm complete another human factors study and provide additional product quality information.
“We remain confident in the efficacy, safety and quality of Linhaliq and will request a meeting with FDA to discuss the topics covered in the CRL with the view to developing plans to move towards resubmission of the Linhaliq NDA as soon as possible. We are committed to continue working on the approval of Linhaliq for NCFBE patients who have very severe disease with high morbidity and mortality and no available treatment options. We thank these patients and their care givers for participating in a decade of clinical research that brought us to this point,” president & CEO Igor Gonda said in prepared remarks. “Our focus is also on the submission in the near future for marketing approval in the European Union.”
If approved, Aradigm’s proprietary inhaled formulation of ciprofloxacin would be the only product on the market to treat non-cystic fibrosis bronchiectasis.
ARDM shares were down -40% in premarket activity today, trading at $1.36 apiece.
