Almirall S.A. (ALM), an international pharma company based on innovation and committed to health, has received the European Commission marketing approval to Eklira/Bretaris Genuair(aclidinium 322µg twice daily) in all EU member states, plus Iceland and Norway, as a maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD), following the positive recommendation received from the CHMP in May this year.
“Patients with COPD have a high symptom burden, which can have important effects on their quality of life”, commented Professor Paul W Jones, from St George’s Hospital, University of London, and principal investigator of the ATTAIN phase III study.“The European approval of aclidinium is good news for the healthcare community because improvements observed in health status and symptoms within the trials can finally be translated into benefits for patients in every-day practice”, he added.
Clinical efficacy studies showed that aclidinium provides around the clock 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%. 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]).
“Almirall and its European partner Menarini are pleased with the approval of Eklira/Bretaris Genuair, an important milestone in Almirall’s respiratory franchise, one of our key R&D areas”said Eduardo Sanchiz, chief executive officer, Almirall. “We are convinced from our large set of scientific data that aclidinium will help patients in Europe to reduce COPD symptoms and improve their quality of life”.
Aclidinium showed a good safety profile, with the most frequently reported adverse reactions being headache (6.6%) and nasopharyngitis (5.5%). Importantly, the incidence of typical anticholinergic adverse events was low and comparable to placebo (e.g. dry mouth and constipation were both <1%).
Menarini will have joint commercialisation rights across the majority of EU member states (excluding the UK, the Netherlands and the Nordic countries where Almirall retains sole marketing rights for the product)as well as Russia, Turkey and other CIS countries under the brand name BretarisGenuair, whilst Almirall will market the product in Europe as Eklira Genuair.
Aclidinium is being developed worldwide and has been recently approved in the USA 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 and with Daewoong in Korea. Almirall holds the rights for the rest of the world.
Aclidinium is administered to patients using the novel multidose dry powder inhaler (MDPI), Genuair. The inhaler comes loaded and assembled and ready for immediate use. Almirall’s inhaler was designed with a “click and colour” feedback system which, through a 'colour control window' and an ‘audible click’, indicates that the patient has inhaled the dose 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.