GlaxoSmithKline got a small victory Thursday when much of a Food and Drug Administration advisory committee urged modifications of the very stringent warnings on the label for its type 2 diabetes drug Avandia.
Those warnings were borne of concerns that the drug caused increased chances of heart attacks. A link to Friday's Inquirer story is here.
But the diabetes drug world has changed a lot since Avandia reached its heights in use and revenue, which was 2006, when it had more than $3 billion in sales.
In 2011, Avandia sales were $513.7 million, but that figure slid to $$265.4 million in 2012, according to the GSK annual report (link here).
The world population of type 2 diabetics has grown and other drug companies have rushed to sell medicine to those people. There are many slices of that market and many drugs. Use of statins to cut cholesterol and, thereby control heart disease, has also increased.
GSK first got approval for the drug in 1999. The patent has expired, GSK no longer promotes the drug and Teva Pharmaceuticals got approval on Jan. 25 of this year to sell a generic version of the drug. A link to the Teva Orange Book page for this drug is here.
GSK is based in London, but has operations in and around Philadelphia. Teva is based in Israel and has facilities in Montgomery and Bucks Counties.
One thing not impacted by Thursday's decision is the legal liabilities GSK still faces. It paid $3 billion in 2012 to settle federal charges, including guilty pleas on three criminal counts, one of which related to withholding safety information about Avandia. But there is lot of Avandia litigation left.
From the 2012 annual report is this passage, which only related to the litigation in two different Philadelphia courts:
"The Group has been named in product liability lawsuits on behalf of individuals asserting personal injury claims arising out of the use of Avandia. The federal cases filed against the Group are part of a multi-district litigation proceeding pending in the United States District Court for the Eastern District of Pennsylvania. Cases have also been filed in a number of state courts. Cases filed in state court in Philadelphia have been coordinated in the Mass Tort Program."