US regulators question safety data for Forest/Almirall COPD drug
This article was originally published in Scrip
Executive Summary
US regulators on 21 February raised concerns about the small size of the safety databases from the clinical trials of Forest Laboratories' and Almirall’s experimental inhaled chronic obstructive pulmonary disease (COPD) drug aclidinium bromide, in light of adverse cardiovascular risks associated with other medicines in the same class, known as anticholinergic agents.