Another DI prediction comes true – FDA requires Avandia, Actos to have Black Box warning
In what is almost a non-event with Avandia sales continuing to plummet, yesterday the Food and Drug Administration (FDA) did what Diabetic Investor said they would and required a Black Box warning for the drug. The agency took no chances with the TZD class and also required the same warning for Actos, even though the drug appears safer than Avandia.
The complete warnings for both drugs can be found at
Avandia – http://www.fda.gov/cder/drug/InfoSheets/HCP/rosiglitazone200707HCP.htm
Actos – http://www.fda.gov/cder/drug/InfoSheets/HCP/pioglitazoneHCP.htm
While this results was expected one has to wonder after all the controversy will any good come from all this. Based on how this entire situation was handled Diabetic Investor is not optimistic and sees more harm than good. This move also casts a dark cloud over every company with a type 2 drug in clinical trials. No one, and we suspect, not even the FDA knows how they will look at drug candidates going forward.
Sadly, another Diabetic Investor prediction also came true, in that the big losers here are the millions of patients with type 2 diabetes and the physicians who treat them. Hopefully in the future clearer standards will be developed that will assist patients and their physicians. In the real world all drugs carry some risk, risks which should be clearly identified so that informed decisions can be made.
Finally, for those wondering if the worst is over for GlaxoSmithKline (NYSE:GSK) and whether now is a good time to buy shares, the answer is split. On a long term basis Diabetic Investor believes GSK is solid well-run company, however in the near term we’re not convinced shares have bottomed out.
David Kliff
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