The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 12 to 2 in favor of approval for Forest Laboratories’ and Almirall’s NDA for a 400 μg twice daily dose aclidinium bromide inhalation powder to treat COPD. Although the briefing materials for the advisory committee meeting raised questions about the safety of inhaled long-acting muscarinic agents (LAMAs) such as aclidinium, PADAC members voted 10 to 3 in favor of the product’s safety with 1 abstention. The vote in favor of efficacy was unanimous.
Forest licensed US rights to aclidinium bromide from Almirall, and the two companies have been co-developing the product, which is delivered using a multi-dose DPI. An FDA decision is expected by mid-2012.
Read the Forest and Almirall press release.
