The Danish Health and Medicines Authority has granted general reimbursement to Almirall's Eklira Genuair (aclidinium 322µg twice-daily), as a maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients, following a positive recommendation by the Danish Reimbursement Committee and the marketing approval from the European Commission. Forthcoming launches are expected in the UK and Germany, which, together with the Nordic countries, account for almost half of the European COPD market.
Clinical efficacy studies showed that aclidinium provides significant and sustained bronchodilation and symptoms control from the first dose. These benefits were evident within 30 minutes of the first dose. It also reduced moderate and severe exacerbations by approximately 30 per cent. In pivotal studies, patients treated with aclidinium needed less rescue medication than patients treated with placebo (p=0.005). It also improved COPD symptoms such as dyspnoea, cough and sputum production.
In addition, the studies demonstrated that aclidinium provided clinically meaningful improvements in breathlessness (assessed using the Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St George's Respiratory Questionnaire [SGRQ]). Aclidinium showed a good safety profile, with the most frequently reported adverse reactions being headache (6.6 per cent) and nasopharyngitis (5.5 per cent). Importantly, the incidence of typical anticholinergic adverse events was low and comparable with placebo (eg, dry mouth and constipation were both <1 per cent).
Aclidinium is a novel, long-acting inhaled muscarinic antagonist (sometimes referred to as an anticholinergic) that has a long residence time at M3 receptors and a shorter residence time at M2 receptors. When given by inhalation, aclidinium leads to bronchodilation by inhibiting airway smooth muscle contraction. Aclidinium is rapidly hydrolysed in human plasma to two major inactive metabolites.
Aclidinium is administered to patients using a multi-dose dry powder inhaler (MDPI), Genuair. This inhaler was designed with a "click and colour" feedback system, which, through a 'coloured control window' and an audible click, indicates that the patient used the inhaler correctly. It also incorporates significant safety features such as a visible dose indicator, an anti-double-dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.
Aclidinium is being developed worldwide and has been recently approved in the US by the FDA where it will be marketed by Forest Laboratories and marketed under the name of Tudorza Pressair. In Japan, the product is in development in partnership with Kyorin Pharmaceutical and with Daewoong Pharmaceutical in South Korea. Almirall holds the rights for the rest of the world.