Today, FDA released an army of briefing documents ahead of the advisory committee re-review of GlaxoSmithKline's diabetes drug Avandia (rosiglitazone). To read all of the documents for yourself, click here.
Friday, July 09, 2010
While one could argue that any number of issues will be key in helping FDA determine what regulatory action to take on Avandia, we believe the key to the whole debate is quite simple, actually: question 7.
FDA asked the joint Endocrinologic & Metabolic and Drug Safety & Risk Management Advisory Committees a large number of questions--six of which are formal voting questions with multiple options.
Most of the headline attention will be focused on question 8: "What regulatory action does the panel recommend FDA take on Avandia? A) Allow continued marketing and revise the current label to remove the boxed warning and other warnings regarding risk of ischemic CV events, or B)Allow continued marketing and make no changes to the current label, or C) Allow continued marketing and revise the current label to add warnings, or D) Allow continued marketing, revise the current label and add additional restrictions on use, or E) Withdrawal from the US market."
But none of the questions may be more important to FDA decision makers than the preceding question, number 7:
"Rosiglitazone and other oral anti-diabetic therapies share the same indication of improving glycemic control in patients with Type-2 diabetes. Based on the available data, please discuss the benefit-to-risk profile of rosiglitazone in the context of other available anti-diabetic therapies."
In other words, does Avandia provide a unique benefit over existing therapies on the market? Our bet is that FDA decision makers will be paying particularly close attention to the answers provided by committee members to question 7.
FDA knows what its regulatory options are when it comes to Avandia. But the agency will be looking for arguments--even if they are in the minority--that make the case for a unique Avandia benefit over everything else.
It will be a difficult argument to make.