“All I want for Christmas is Two”: The Advent of Novel Fixed-Combination Inhalers for COPD and Outlook for 2014

Looking back, there has never been a year with a greater number of novel drug approvals or filings in the history of pharmacological treatment of chronic obstructive pulmonary disease (COPD). As COPD treatment often involves a combination of therapies in clinical routine, the recent approval of two novel fixedcombination inhalers is of particular interest: the once-daily combination of an inhaled corticosteroid (ICS), fluticasone furoate, with a long-acting beta-agonist (LABA) vilanterol (Breo /Relvar , GlaxoSmithKline/Theravance), was approved by the Food and Drug Administration for the US market (press release October 30, 2013 [1]), and the oncedaily fixed combination of two already marketed bronchodilator monotherapies, the long-acting beta-agonist indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium (Ultibro , Novartis), was granted approval by the European Medicines Agency for countries of the EU [2]. In addition, another once-daily LABA/LAMA combination (vilanterol/umeclidinium, Anoro , GlaxoSmithKline/Theravance) has received a positive opinion of the Pulmonary and Allergy Drugs Advisory Committee recommending approval (press release September 10, 2013 [3]), while finally a third, twice-daily LABA/LAMA combination (formoterol/aclidinium, Acliform , Almirall/ Forest) was filed for approval by EU regulators (press release November 4, 2013 [4]). Despite the fact that neither of these drugs represent new pharmacological principles, the development process of these therapies has nonetheless fueled the current evidence-base of COPD by providing an abundance of data from large, well-controlled clinical trials. These data, in result, will undoubtedly impact on the COPD treatment approach, as reflected in global or regional guidelines and strategy K. M. Beeh (&) insaf Respiratory Research Institute, Wiesbaden, Germany e-mail: [email protected]