Thursday after the bell, pharmaceutical giant Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration Advisory Committee or FDA Panel has backed its claim that Spiriva HandiHaler reduced exacerbations in patients with chronic obstructive pulmonary disease or COPD.
The panel voted 11 to 1 that Pfizer has provided substantial and convincing evidence to support its claim that its drug Spiriva HandiHaler or tiotropium bromide inhalation powder reduces worsening of symptoms in patients with COPD in a supplemental new drug application or SNDA.
The advisory committee also voted affirmatively that data from the UPLIFT trial or Understanding Potential Long-term Impacts on Function with Tiotropium trial adequately addressed potential safety concern for an increased risk of stroke or adverse cardiovascular events; consistent with the current product label. However, it must be noted that UPLIFT did not meet its primary endpoint.
The advisory committee reviewed pivotal data from a six-month trial of 1,829 COPD patients and secondary endpoints from a four-year trial of approximately 6,000 COPD patients. The advisory committee makes recommendations to the FDA, which the agency considers in its final decision.
PFE closed Thursday's regular trading session at $18.11, down $0.08 or 0.44%, on the NYSE. However, in the after hours, the stock rose $0.04 or 0.22% to trade at $18.15.
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