The votes are in, and it isn't good news for GlaxoSmithKline's (NYSE: GSK) Avandia (rosiglitazone). Twelve members of an FDA panel voted to recommend market withdrawal; 10 others voted for continued marketing with restrictions on use and revised label and seven to revise current labels to add additional warnings.
During the intense two-day meeting, GSK's RECORD trial was slammed as lacking quality. Dr. Steven Nissen (photo) of the Cleveland Clinic said with an alternative in the same class--Actos (pioglitazone)--with favorable effects on cardiovascular outcomes, "continued marketing of rosiglitazone cannot be medically or ethically justified." And one panel member said that at the time of Avandia's approval, the benefits outweighed its risks, but now, it's the opposite.
In the early afternoon Wednesday, 18 of 33 panel members said there is sufficient evidence to suggest there is an increased risk of ischemic cardiovascular events in Type 2 diabetes patients relative to non-thiazolidinedione anti-diabetic agents. And 21 voted there is sufficient evidence of an increased risk of ischemic cardiovascular events in patients with the disease relative to rival Actos. Acting Chairman Kenneth Burman was among those who voted that he couldn't make a determination at this time on these questions.
Editor's Note: Title was changed to clarify panel's vote.