Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

Treatment of patients with chronic obstructive pulmonary disease

Posted by fidest press agency su mercoledì, 3 aprile 2019

Almirall, S.A (ALM), announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Duaklirâ (aclidinium bromide/formoterol 400/12 mg, twice daily), for the treatment of patients with chronic obstructive pulmonary disease (COPD).
Duaklir® offers a fixed-dose combination of a novel long-acting muscarinic antagonist (LAMA), aclidinium bromide and a fast long acting beta2-agonist (LABA), formoterol fumarate, administered through the GENUAIR® inhaler device.The FDA has approved Duaklir® based on the positive results of the AMPLIFY study, that shows Duaklir® significantly improved lung function in patients with moderate to severe COPD compared to each individual component (either aclidinium bromide or formoterol). The Phase III AMPLIFY study also proved that the efficacy, safety and tolerability profiles for aclidinium bromide and formoterol were consistent with current experience. 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. This approval by the FDA in the US means another positive step in the partnership of Almirall and AstraZeneca.In addition this is the third product discovered in the R&D Center of Almirall approved by the FDA.
The positive results of the Phase IV ASCENT trial for Tudorza® Pressair® (aclidinium bromide 400 μg, twice-daily) with 3.600 patients demonstrating a statistically significant reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo, has been translated in a relevant change in the Package Insert of this product in the US and also reflected in the current approval of Duaklir®.On 1st November 2014, Almirall entered an agreement to transfer the rights for the development and commercialisation of its respiratory franchise, as well as its pipeline of investigational novel therapies to AstraZeneca. This global collaboration included milestones associated to development, launch and future Duaklir® sales in US.Almirall could receive additional milestones and royalties, which have not been disclosed.Almirall remains positive about this partnership that has allowed to maximize the return and value of the company’s assets and capabilities.


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