Posted by Michael Wonder on 11 Mar 2018
Aradigm submits marketing authorisation application to EMA for EU marketing approval of Linhaliq in non-cystic fibrosis bronchiectasis
9 March 2018 - Aradigm Corporation today announced it has submitted its marketing authorisation application to EMA for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infection with Pseudomonas aeruginosa (P. aeruginosa).
In accordance with Article 8(3) and Annex I, Part II.7 of Directive 2001/83/EC, Aradigm is submitting a mixed appliaction for Linhaliq that is based on the positive Phase 3 pivotal clinical trial ARD-3150-1202 (ORBIT-4) and supporting evidence from Phase 3 study ARD-3150-1201 (ORBIT-3) and Phase 2b study ARD-3150-0902 (ORBIT-2), together with other supporting evidence from proprietary preclinical and clinical studies, as well as referencing additional information about ciprofloxacin from publicly available sources.
The EMA has a 21-day validation review period to determine whether the MAA is complete before starting the procedure.
