On September 10, 2013, a US Food and Drug Administration (FDA) panel voted to recommend approval of a new drug to treat chronic obstructive pulmonary disease (COPD) called Anoro Ellipta. The overall FDA decision on approval is expected by the end of 2013; the FDA is not required to follow the advice of the panel, but it generally does. Despite the panel's overwhelmingly positive vote, controversy surrounds this drug due to its potential cardiac side effects.
Anoro Ellipta is actually two drugs in one: a long-acting muscarinic antagonist (LAMA) called umeclidinium (UMEC) and a long-acting beta agonist (LABA) called vilanterol (VI). Due to concerns particularly regarding UMEC, two panel members voted against approval, and three voted "no" on whether the drug was proven to be safe. Sammy Almashat, MD, MPH, testified on behalf of consumer advocacy group Public Citizen to recommend against approval of Anoro Ellipta. "Public Citizen opposes this approval," Dr. Almashat stated, "because of the uncertainty surrounding the alarming cardiac safety signal seen in the pre-approval studies [...] It is clear that this is an unanswered question that should not be taken lightly given the presence of a plausible mechanism, similar concerns with other LAMAs, and the fact that COPD patients are at higher risk for heart attacks than the general population."
Discussion at the FDA panel meeting centered on information presented in a government-written backgrounder, including information from safety trials, none of which lasted longer than 12 months, and efficacy trials. In the section entitled "Non-fatal serious adverse events," the FDA noted an "imbalance": 13 cases of myocardial infarction / ischemic disease were reported in the treatment arms of the primary efficacy trials, and zero cases were reported in the placebo arm. Rather than delaying approval of the drug, however, FDA panel members recommend approving it and monitoring adverse events, including myocardial infarctions, via post-marketing surveillance. In his testimony, Dr. Almashat noted that post-marketing studies can take years -- the study for COPD treatment aclidinium is scheduled to be completed six years after the drug was first licensed -- and two members of the FDA panel agreed. It remains to be seen what the FDA will decide in December.