(RTTNews) -  Pfizer Inc. (PFE: News ) said Thursday that the U.S. Food and Drug Administration or FDA Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application provide substantial and convincing evidence to support the claim that SPIRIVA HandiHaler or tiotropium bromide inhalation powder reduces worsening of symptoms in patients with chronic obstructive pulmonary disease or COPD.

The advisory committee also voted affirmatively that data from the UPLIFT or Understanding Potential Long-term Impacts on Function with Tiotropium trial adequately addressed the potential safety concern for an increased risk of stroke or adverse cardiovascular events.

The supplemental new drug application or sNDA was filed by Boehringer Ingelheim Pharmaceuticals, Inc., the U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer added that the company intends to work with the FDA during the final stages of its review of the sNDA.

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by RTT Staff Writer

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