Added benefit of Almirall's aclidinium bromide is not proven, says Germany's IQWiG

The drug aclidinium bromide, trade names Eklira, Bretaris from Spain’s largest drugmaker Almirall (ALM: MC), which has been approved in the European Union since October 2012 for widening the narrowed airways of adults with chronic-obstructive pulmonary disease (COPD), has been the subject of a German Institute for Quality and Efficiency in Health Care (IQWiG) examination of its added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).

Disappointingly for Almirall, the drugs watchdog concluded that no proof of an added benefit of aclidinium bromide compared with the appropriate comparator therapy (ACT) can be inferred from the data in the drug manufacturer's dossier. No robust results were submitted by the manufacturer in its dossier: for the direct comparison, there were no studies of an adequate duration. The data for the indirect comparison were incomprehensible for several reasons. Therefore the added benefit is not proven.

The ACT specified by the Federal Joint Committee (G-BA) takes account of the graded treatment scheme of the current National Care Guidelines for COPD: from Stage II of the disease, long-acting beta-2 sympathomimetics (formoterol, salmeterol) and/or long-acting anticholinergics (tiotropium bromide) are to be used; from Stage III/IV, if there are more than 2 severe attacks (exacerbations) per year, inhaled corticosteroids (ICS) are recommended in addition. The manufacturer followed these requirements and chose tiotropium bromide (tiotropium for short) as ACT.