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U.S. regulators have requested that six of the most widely used anti-psychotic drugs carry a warning that they can increase the risk of elevated blood sugar and diabetes, Eli Lilly and Co. said on Wednesday.
Indianapolis-based Lilly, which makes the top-selling schizophrenia treatment Zyprexa, said the U.S. Food and Drug Administration is also seeking the warning on the product labeling for Johnson & Johnson’s rival Risperdal, Novartis AG’s Clozaril, Bristol-Myers Squibb Co.’s Abilify, AstraZeneca Plc’s Seroquel and Pfizer Inc.’s Geodon.
Lilly, which received a letter from the FDA on Monday, said more research is needed into the possible link.
All six of the drugs are so-called atypical anti-psychotics, a newer generation of medicines that do not cause some of the troublesome side effects, such as tremors, seen in older treatments.
FDA spokeswoman Susan Cruzan confirmed the agency had asked makers of atypical anti-psychotics to add the new warning. She said epidemiological studies suggested a link between treatment with the drugs and an increased risk of diabetes.
Analysts have speculated the FDA might require the diabetes warning for some or all of the atypical drugs, following results last month of a long-awaited study that linked three of the medicines to higher incidence of the disease.
The study, involving almost 20,000 schizophrenia patients treated at veterans’ hospitals and clinics across the United States, showed patients taking Seroquel had 3.34 times as many cases of diabetes as those on older drugs.
With Risperdal, the rate was 1.49 times, or 49 percent, greater than that of the older drugs. Patients on Zyprexa were 1.27 times more likely to become diabetic.
The veterans study erased much of the stigma from Zyprexa, whose U.S. sales have slowed in the past year because it tends to cause more weight gain among patients than other atypicals.
Because obesity is a leading cause of Type II diabetes, many doctors and industry analysts had wrongly assumed Zyprexa posed the greatest diabetes risk to patients.
“The new label warning will have very limited impact on sales of any of the atypical drugs because doctors are already very familiar with their link to diabetes,” said Sena Lund, an analyst with Cathay Financial LLC.
He said the warning puts all six drugs on a level playing field, and could thereby help Zyprexa achieve Lilly’s 2003 forecast of “mid-teen” percentage sales growth.
“Doctors will focus on the effectiveness of these drugs instead of diabetes risk,” said Lund, who predicted few doctors would switch to older drugs because they are less effective than the atypicals.
OrbiMed Advisors analyst Trevor Polischuk said the new labeling requirement “means Zyprexa is no longer being singled out as a diabetes-causing drug, which could actually help boost its sales.”
Zyprexa last year boasted sales of $3.69 billion — one-third of Lilly’s overall revenues. Risperdal is one of Johnson & Johnson’s top products, with 2002 sales of $2.3 billion, while AstraZeneca’s Seroquel garnered $1.1 billion in sales.
Concerns about Zyprexa have played mostly into the hands of Bristol-Myers, whose recently launched Abilify does not cause significant weight gain among schizophrenics — a population that is already at high risk of developing Type II diabetes.
Shares of Lilly slipped 26 cents to close at $60.74 on the New York Stock Exchange. Johnson & Johnson’s stock dropped 63 cents to $50.22, while the U.S.-listed shares of Novartis fell 14 cents to $39.98. (Additional reporting by Jed Seltzer and Lisa Richwine)
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