Quoted from http://www.reuters.com/article/latestCrisis/idUSN17544425
US FDA staff question Pfizer lung drug data
By Lisa Richwine
WASHINGTON, Nov 17 (Reuters) - U.S. reviewers will ask an advisory panel about statistical issues and safety concerns as they weigh a proposed new claim for a lung drug sold by Pfizer Inc and Boehringer Ingelheim, documents released on Tuesday said.
The companies are asking the Food and Drug Administration for permission to claim the drug Spiriva reduces flare-ups of chronic obstructive pulmonary disease (COPD).
Spiriva is currently considered the gold standard treatment for COPD, or "smoker's lung," commonly caused by cigarette smoke and other harmful fumes and characterized by a persistent obstruction of airflow in the lungs which results in breathlessness.
It is approved for treating COPD but not specifically for reducing flare-ups, a claim made by GlaxoSmithKline's competing drug Advair.
FDA reviewers, in an analysis prepared for an outside advisory committee, said in two Boehringer studies of Spiriva "there are statistical issues with consideration of an exacerbation claim, which may preclude a single trial from supporting the claim."
The agency also said it will ask the panel at a meeting on Thursday to consider recent safety concerns surrounding the possibility of strokes, cardiovascular-related deaths and heart attacks with Spiriva, a daily inhaled medicine.