Aradigm Announces the EMA Has Completed Its Validation of the MAA Submission

Aradigm Corporation announced the completed formal validation by the European Medicines Agency (EMA) of the Marketing Authorisation Application (MAA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa). The completion of the MAA validation is commensurate with the start date of the review procedure on March 29, 2018.

The EMA review of the MAA for Linhaliq will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use (CHMP) expected within 210 days (less any clock-stops for the applicant to provide answers to question(s) from the CHMP). After the adoption of a CHMP opinion, a final decision regarding the MAA assessment is carried out by the European Commission on Day 277 of the procedure.

The validation of the MAA submission is a milestone event for Aradigm. We look forward to working with EMA to gain approval for Linhaliq.

If approved by the European commission, Linhaliq will provide a much-needed treatment for patients with NCFBE with chronic lung infections with P. aeruginosa.