Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 341

NdP Phase III AMPLIFY study shows Duaklir significantly improves lung function in moderate to very severe stable COPD

Posted by fidest press agency su lunedì, 11 settembre 2017

barcellonaBarcelona – Almirall has announced positive top-line results, which shows that Duaklir (aclidinium bromide/formoterol 400µg/12µg twice-daily) met the primary endpoints in the AMPLIFY high-level read-out, demonstrating a statistically significant and clinically relevant improvement in lung function in moderate to very severe stable chronic obstructive pulmonary disease (COPD) patients compared to each individual component (either aclidinium bromide or formoterol).The Phase III AMPLIFY study proves that the efficacy, safety and tolerability profiles for aclidinium bromide and formoterol were consistent with current knowledge. In comparison to tiotropium bromide 18µg once-daily, both Duaklir and aclidinium bromide monotherapy demonstrated significantly higher levels of bronchodilation during the night-time, whilst aclidinium bromide monotherapy showed non-inferior bronchodilation to tiotropium over 24 weeks.Eduardo Sanchiz, Chief Executive Officer at Almirall said: “These results represent a significant milestone for Almirall’s respiratory business transferred to AstraZeneca, as they support the previous regarding of Duaklir and will contribute to making this combination treatment available to COPD patients in the US”. Based on the positive results of the AMPLIFY study, AstraZeneca is preparing a New Drug Application (NDA) submission to the US FDA for Duaklir (aclidinium bromide/formoterol 400/12mg).The global collaboration between Almirall and AstraZeneca includes milestones associated to development, launch and future Duaklir sales in US. “This agreement has allowed us to evolve our respiratory strategy to maximise the return and value of our assets and capabilities while it will keep improving the financial position of Almirall and contributing to the company’s long-term growth,” commented Eduardo Sanchiz.Almirall entered an agreement to transfer to AstraZeneca the rights for the development and commercialisation of its respiratory franchise, as well as its pipeline of investigational novel therapies in November 2014. The franchise includes products such as Duaklir, the combination of aclidinium with formoterol (LAMA/LABA) approved by the European Medicines Agency (EMA) as a maintenance treatment for patients with chronic obstructive pulmonary disease.

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