NEW YORK (Reuters) - A possible tighter U.S. label on GlaxoSmithKline Plc’s (GSK.L) troubled Avandia drug may not be a disaster for the diabetes treatment, the company’s chief executive said on Monday.
When asked whether Avandia could return to its former level of profitability even with a second so-called black-box warning, Glaxo CEO Jean-Pierre Garnier said in a phone interview: “Absolutely. It all depends on what the language is.”
The U.S. Food and Drug Administration is expected to decide any day on a labeling revision for Avandia, Glaxo’s second-biggest product — sales of which have plummeted since a report in May linking it to increased heart attack risk.
“It’s not the black box that matters or the lack of black box, that’s not important to me; it’s — what is it saying?” Garnier told the Reuters Health Summit in New York.
The FDA has been reviewing the drug’s label since July, when an agency advisory panel voted to keep Avandia on the market but with new warnings about its risks.
Avandia, which sold 1.6 billion pounds ($3.3 billion) worldwide in 2006, already carries one FDA black box warning for another condition, heart failure, when a weakened heart cannot pump blood effectively.
A warning for the risk of heart attack would be more serious.
But Garnier said it was important that the very small heart attack risk of two patients per 10,000 identified in the pooled, or meta, analysis be kept in perspective and he expected the FDA to adopt a “balanced” approach.
“The absence of Avandia or lack of availability of Avandia would actually create a problem,” he added.
“Hopefully some of those patients will come back and realize that things are not the way they’ve been portrayed at the beginning of this unfortunate issue.”
Sales of Avandia have plummeted since May, to the benefit for Takeda Pharmaceutical Co Ltd’s (4502.T) rival drug Actos. Avandia revenues in the United States fell 48 percent from the year-ago period in the three months to September 30.
(For summit blog: summitnotebook.reuters.com/ )
Reporting by Ben Hirschler and Sam Cage; Editing by Brian Moss