Avandia’s sales may suffer from FDA ruling
NEW YORK — An advisory panel’s call for stronger warnings about heart risks tied to GlaxoSmithKline PLC’s diabetes drug Avandia may further erode sales that had already been dropping over the past two years.
Food and Drug Administration advisers did not recommend a recall, but label changes they proposed yesterday may eliminate 95 percent of Avandia’s use, said Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio.
Avandia generated $1.1 billion last year for London-based Glaxo, the United Kingdom’s biggest drug maker. That’s one-third of the drug’s revenue before Nissen’s analysis two years earlier linked the medicine to a 43 percent increased risk in heart attacks.
The FDA began reexamining its 2007 decision to keep Avandia on the market after members of Congress voiced concerns and data emerged from almost a dozen new studies.
“This is the industry on trial,’’ Navid Malik, an analyst at Matrix Corporate Capital in London, said yesterday. “The new FDA has a real level of rigor. They’ll be a lot more cautious going forward, and there will be a lot more questions before applications for similar drugs go in for approval.’’
Increased oversight by the FDA may raise the cost of clinical trials and drug development for pharmaceutical companies, Malik said.
The FDA panel recommended Avandia’s fate at the conclusion of a two-day meeting in Gaithersburg, Md. While the agency usually follows the recommendations of its advisers, it is not required to do so.
Glaxo’s shares gained 1.8 percent yesterday in London after the company said it expects to record a $2.4 billion charge in the second quarter to settle legal cases, including lawsuits alleging Avandia led to heart attacks.
The drug maker’s American depositary receipts rose 86 cents, or 2.4 percent, to $37.21 yesterday in New York Stock Exchange composite trading.
An estimated 23.6 million Americans have diabetes, mostly the type 2 variety linked to being overweight and sedentary, according to the National Institutes of Health. The disease is caused by an inability to use insulin to break down blood sugar into energy and can increase the risk of heart disease, stroke, and kidney damage.
Avandia, approved for sale in the United States in 1999, works by increasing the body’s sensitivity to insulin.
Questions about how Avandia affects the heart arose even before it won US approval. The drug decreases hemoglobin levels, raises cholesterol, and can cause swelling and weight gain. European regulators required the company to conduct a study of Avandia’s cardiovascular safety as a condition of its approval the following year. Not until researchers compiled results of several studies did they find patients taking Avandia may be at higher risk for cardiovascular disease.
