) Avandia is available for type II diabetes. Avandia came under
the FDA scanner in 2007 after an article in the New England
Journal of Medicine (NEJM) linked the use of Avandia
(rosiglitazone) with increased risk of cardiovascular events.
Following the report Glaxo revised the U.S. label on Avandia.
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In 2010, the European Medicines Agency (EMA) banned Avandia,
while the FDA severely restricted the use of the drug. Annual
sales of Avandia have fallen drastically to £6 million (in 2012)
from £1.6 billion in 2006.
In Nov 2013, Glaxo announced that the U.S. Food and Drug
Administration (FDA) has eased the restrictions on Avandia use.
The FDA has suggested label modification about cardiovascular
safety apart from certain changes to the Risk Evaluation and
Mitigation Strategy (REMS) program. The FDA has waived the post
market study requirement.
In Jun 2013, the joint advisory committee (comprising the
Endocrinologic and Metabolic Drugs Advisory Committee and the
Drug Safety and Risk Management Advisory Committee) to the FDA
voted in favor of easing safety restrictions related to Avandia.
Of the 26-member panel, 13 voted in favor of modifying and
7 in favor of removing the Avandia REMS program. However, 5
members were in favor of continuing the REMS and 1 recommended
removal of Avandia from the U.S. market.
We remind investors that the Rosiglitazone Evaluated for
Cardiovascular Outcomes and Regulation of Glycemia in Diabetes
(RECORD) trial did not show an elevated risk of heart attack or
death in patients being treated with Avandia versus standard
We note that Avandia patents have already expired in the U.S. We
believe that with major players like
) already in the diabetes market, Avandia sales are not likely to
Glaxo, a large cap pharma company, carries a Zacks Rank #3
(Hold). Some better-ranked stocks in the large cap pharma space
), which carries a Zacks Rank #2 (Buy).