Like other panelists who did not support approval, Dr. Paula Carvalho, professor of medicine in the division of pulmonary and critical care medicine, University of Washington, Seattle, said the benefit-risk profile was not adequate. She added that she was more impressed by the effect that treatment with VI 25 mcg alone had on COPD exacerbations than with the combination. Also voting against approval was Peter Peduzzi, Ph.D., professor of public health at the Yale School of Public Health in New Haven, Conn., who said that the impact on trough FEV1 appeared to be driven by the VI component, and like others voting against approval, he cited safety issues.
If approved, GSK plans to market the product as Breo Ellipta. The FDA’s deadline for making a decision on the approval is May 12. The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist might be given a waiver, but not at this meeting.
The product is under review for both COPD and asthma in the European Union and in Japan. It is not under review for asthma in the United States.