AstraZeneca sales and marketing update

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) said in a dossier assessment reexamining Bretaris/ Eklira Genuair aclidinium bromide from AstraZeneca that the drug had “considerable added benefit” to treat grade III chronic obstructive pulmonary disease (COPD) in patients with fewer than two flare-ups per year. IQWiG said the company requested a new dossier assessment based on newly submitted data, which included direct comparisons with formoterol.

IQWiG had evaluated the inhalable long-acting, selective M2 and M3 muscarinic receptor antagonist delivered using the Genuair inhaler in 2012 as monotherapy and last year as a fixed-dose combination with formoterol. The agency determined an added benefit for the fixed-dose combination but not the monotherapy (see BioCentury, Jan. 7, 2013). ...