Choking on Ariflo
GlaxoSmithKline plc's Ariflo cilomilast, a phosphodiesterase-4 (PDE-4) inhibitor for treatment of chronic obstructive pulmonary disorder, is the first compound in its class to get as far as an FDA marketing application. While the agency's Pulmonary-Allergy Drugs Advisory Committee voted 7-3 on Friday not to recommend approval of Ariflo, this doesn't close the door on the product or the drug class. The advisory committee's discussion contained ideas that, if pursued, may facilitate the eventual approval of the product or of other compounds in the class.
While the committee had no trouble concluding that the pharma company had not hit its clinical targets, it eased doubts about the safety of the drug class and opened the door to different endpoints that might better make the case for the strategy of using PDE-4 inhibitors to intervene in the cascade of events that leads to lung tissue inflammation.
The panel warned, however, that much longer trials might be necessary to demonstrate clinically useful outcomes.
According to NIH, COPD is "a term that is used for two closely related diseases of the respiratory system: chronic bronchitis and emphysema. In many patients these diseases occur together." Most cases are caused by years of heavy cigarette smoking. "In later