Aradigm Corp. said its respiratory disease drug Linhaliq is not likely to get the backing of the European Medicines Agency in November.
The Hayward, Calif.-based company previously filed a centralized marketing authorization application for Linhaliq for treating non-cystic fibrosis bronchiectasis patients with chronic lung infections with P. aeruginosa. Non‐cystic fibrosis bronchiectasis is a condition in which the bronchial tubes in the lungs are scarred and widened.
Aradigm said it received feedback, following an oral explanation with the EU agency, that the drug is likely to receive a negative opinion from the EMA's Committee for Medicinal Products for Human Use.
Amsterdam-based EMA makes recommendations to the European Commission, which ultimately decides whether to approve or reject manufacturers' applications for marketing approval in the European Union.
Meanwhile, the company is also seeking approval in the U.S. for the drug, known in the U.S. as Apulmiq, for the same indication. In January, the company completed an independent third-party evaluation of two phase 3 studies for the therapy as requested by the U.S. Food and Drug Administration.
In February, Aradigm filed for bankruptcy protection and said it intends to begin selling substantially all of its assets.