Back To: Home

CLICK HERE FOR WHAT'S NEW IN:
 




 

GSK and Theravance COPD therapy’s safety data under scrutiny by FDA
October 2013
SHARING OPTIONS:

SILVER SPRING, Md.—Agency staff at the U.S. Food and Drug Administration (FDA) have released documents stating that the drug candidate Anoro Ellipta (vilanterol/umeclidinium) from GlaxoSmithKline PLC and Theravance demonstrated strong efficacy at both doses in patients with chronic obstructive pulmonary disorder. That was tempered, however, with the reviewers' comment that although the safety database for the therapy is fairly large, it is "not entirely conclusive, particularly in regards to cardiovascular safety." Imbalances were seen in specific subsets, namely for non-fatal myocardial infarction, and while no clear correlation was made between the incidents and the therapy, the staff said the imbalances "will be a topic for further discussion." The FDA's final decision on Anoro Ellipta is expected by Dec. 18.

Back



PAGE UTILITIES


CONTACT US
DDNEWS
1000 N West Street, Suite 1200,
Wilmington, Delaware, 19801
Ph: 888-781-0328 |  Fax: 705-528-0270
 
© Copyright 2020 Old River Publications LLC. All righs reserved.  |  Web site managed and designed by OffWhite.