Date: 2014-11-24
Type of information: Granting of a Market Authorisation in the EU
Product name: Duaklir® Genuair®
Compound: aclidinium bromide/formoterol fumarate 340/12 mcg
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Action mechanism: Duaklir® is a fixed-dose combination of already-approved Eklira® (aclidinium bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol. The twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies and is administered by the Genuair® dry powder inhaler device..
Company: AstraZeneca (UK)
Disease: chronic obstructive pulmonary disease
Latest news: * On November 24, 2014, AstraZeneca announced that Duaklir® Genuair® (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation by the European Commission (EC) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). AstraZeneca owns the rights to develop and commercialise Duaklir Genuair in the European Union (EU) following the strategic business combination of Almirall’s respiratory portfolio, which was completed last month. The EU approval of Duaklir Genuair marks an important further step in AstraZeneca\'s inhaled therapy strategy of providing physicians and patients a choice of products uniquely available in both dry powder and pressurised metered dose devices. The EU approval of Duaklir Genuair was based on efficacy and safety data from more than 2,000 patients in 11 clinical studies, conducted in 29 countries worldwide. Results showed that Duaklir Genuair demonstrated statistically significant and sustained improvement in the lung function compared to monotherapy, providing a favourable benefit-to-risk profile.
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