COPD Post-Market Requirements: Cardiovascular Safety Could Evolve to Comparative Trials

02 Mar 2012

• By Cole Werble

Forest's aclidinium breezed through an advisory committee review with three strong votes in favor of approval. The FDA panel, however, also included an interesting call for more head-to-head trials in COPD from the outgoing panel chair. That may impact Forest's Phase IV work--but more importantly it may be a sign of the future expectations for other sponsors in the active COPD development area.

Post-market cardiovascular safety trials are emerging as a standard feature for new anticholinerigcs for chronic obstructive pulmonary disease. The trials are the legacy of FDA’s 2007-2009 post-marketing investigation into the cardiovascular safety profile of Pfizer Inc. /Boehringer Ingelheim Pharmaceuticals Inc.'s long-acting muscarinic antagonist Spiriva (tiotropium).

The safety focus is not a surprise given the agency's long-term interest in inhaled bronchodilators. What is new is that...