Sanofi's Pill Linked to Suicidal Thoug...
doug123
12 Jun 2007
News Source: Bloomberg.com
Sanofi's Pill Linked to Suicidal Thoughts, FDA Says (Update3)
By Angela Cullen and Catherine Larkin
June 11 (Bloomberg) -- Sanofi-Aventis SA's weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents for an expert panel that will recommend whether the three-time delayed drug should be approved.
The medicine, to be known as Zimulti in the U.S., helped patients lose weight at the highest dose of 20 milligrams, the Food and Drug Administration staff said in the documents posted today on the agency's Web site. An agency advisory panel will meet June 13 to discuss whether the product's benefits of reducing weight, cholesterol and blood sugar outweigh its risks.
Zimulti, sold as Acomplia outside the U.S., is the first of a new class of drugs called CB1 antagonists that block receptors in the brain that regulate hunger and food intake, as well as acting directly on fat cells. Paris-based Sanofi expects sales of at least $3 billion a year from Acomplia as its older best- sellers, such as the sleeping pill Ambien, lose patent protection. Profit at Sanofi fell in the first quarter.
``The market is expecting the drug will get approved for obesity, but in light of these comments it could be a quite a close call,'' said Andrew Fellows, an analyst at Helvea Ltd. in London, in a telephone interview.
Shares of Sanofi fell 5 cents, or less than 1 percent, to 67.52 euros at the close of trading in Paris. They've declined 3.7 percent this year, trailing the 16-member Bloomberg Europe Pharmaceutical Index, which has fallen 2.6 percent in the period. Sanofi's U.S. depositary shares, each equal to half an ordinary share, fell 36 cents to $45.14 at 4:02 p.m. in New York Stock Exchange composite trading.
Suicide Concerns
The Sanofi pill was approved last year by regulators in Europe, where it competes with Roche Holding AG's Xenical and Abbott Laboratories' Meridia. Approval in the U.S. would open a market in which a third of the population is considered obese.
The FDA noted two suicides in clinical trials of volunteers testing the drug. The panel will be asked to discuss whether it can establish a causal link between the medicine and suicidal thoughts or actions.
The FDA usually follows the advice of its outside advisers, although it isn't required to do so. The agency will issue a decision by late July. Analysts say the FDA, which has delayed approval of the drug three times, may be wary about Acomplia's side effects.
The agency has come under pressure in recent weeks after a study showed a diabetes drug approved in 1999, GlaxoSmithKline Plc's Avandia, raised the risk of heart attacks.
FDA `Risk Averse'
``It was always suspected that there were safety issues,'' Fellows said. ``In recent times, the FDA has become more risk averse, especially if there is reasonable efficacy but there are question marks over side effects.''
Sanofi is seeking approval of the medicine as an adjunct to diet and exercise for the treatment of overweight people at risk of heart disease or for chronically obese people. The company has asked the FDA to also consider Zimulti as a diabetes treatment.
The drugmaker proposed a risk management plan for the U.S. that would restrict its use, excluding it from patients suffering from psychiatric illness and advising caution in people suffering from epilepsy.
The company is monitoring the drug's use in Europe and South America, where a total of 108,730 people had been prescribed it as of March 1, 2007.
Some patients who took part in clinical trials of Acomplia suffered from mood swings, anxiety and depression. Trial volunteers given the highest dose lost an average 5.3 kilograms (11.7 pounds) over a one-year period compared with a weight loss of 1.4 kilograms (3.1 pounds) among patients given a control pill. Acomplia significantly lowered the level of HbA1c, a measure of blood sugar, to within a safe range.
To contact the reporters on this story: Angela Cullen in Frankfurt at acullen8@bloomberg.net ; Catherine Larkin in Washington at clarkin4@bloomberg.net
Last Updated: June 11, 2007 16:36 EDT
Sanofi's Pill Linked to Suicidal Thoughts, FDA Says (Update3)
By Angela Cullen and Catherine Larkin
June 11 (Bloomberg) -- Sanofi-Aventis SA's weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents for an expert panel that will recommend whether the three-time delayed drug should be approved.
The medicine, to be known as Zimulti in the U.S., helped patients lose weight at the highest dose of 20 milligrams, the Food and Drug Administration staff said in the documents posted today on the agency's Web site. An agency advisory panel will meet June 13 to discuss whether the product's benefits of reducing weight, cholesterol and blood sugar outweigh its risks.
Zimulti, sold as Acomplia outside the U.S., is the first of a new class of drugs called CB1 antagonists that block receptors in the brain that regulate hunger and food intake, as well as acting directly on fat cells. Paris-based Sanofi expects sales of at least $3 billion a year from Acomplia as its older best- sellers, such as the sleeping pill Ambien, lose patent protection. Profit at Sanofi fell in the first quarter.
``The market is expecting the drug will get approved for obesity, but in light of these comments it could be a quite a close call,'' said Andrew Fellows, an analyst at Helvea Ltd. in London, in a telephone interview.
Shares of Sanofi fell 5 cents, or less than 1 percent, to 67.52 euros at the close of trading in Paris. They've declined 3.7 percent this year, trailing the 16-member Bloomberg Europe Pharmaceutical Index, which has fallen 2.6 percent in the period. Sanofi's U.S. depositary shares, each equal to half an ordinary share, fell 36 cents to $45.14 at 4:02 p.m. in New York Stock Exchange composite trading.
Suicide Concerns
The Sanofi pill was approved last year by regulators in Europe, where it competes with Roche Holding AG's Xenical and Abbott Laboratories' Meridia. Approval in the U.S. would open a market in which a third of the population is considered obese.
The FDA noted two suicides in clinical trials of volunteers testing the drug. The panel will be asked to discuss whether it can establish a causal link between the medicine and suicidal thoughts or actions.
The FDA usually follows the advice of its outside advisers, although it isn't required to do so. The agency will issue a decision by late July. Analysts say the FDA, which has delayed approval of the drug three times, may be wary about Acomplia's side effects.
The agency has come under pressure in recent weeks after a study showed a diabetes drug approved in 1999, GlaxoSmithKline Plc's Avandia, raised the risk of heart attacks.
FDA `Risk Averse'
``It was always suspected that there were safety issues,'' Fellows said. ``In recent times, the FDA has become more risk averse, especially if there is reasonable efficacy but there are question marks over side effects.''
Sanofi is seeking approval of the medicine as an adjunct to diet and exercise for the treatment of overweight people at risk of heart disease or for chronically obese people. The company has asked the FDA to also consider Zimulti as a diabetes treatment.
The drugmaker proposed a risk management plan for the U.S. that would restrict its use, excluding it from patients suffering from psychiatric illness and advising caution in people suffering from epilepsy.
The company is monitoring the drug's use in Europe and South America, where a total of 108,730 people had been prescribed it as of March 1, 2007.
Some patients who took part in clinical trials of Acomplia suffered from mood swings, anxiety and depression. Trial volunteers given the highest dose lost an average 5.3 kilograms (11.7 pounds) over a one-year period compared with a weight loss of 1.4 kilograms (3.1 pounds) among patients given a control pill. Acomplia significantly lowered the level of HbA1c, a measure of blood sugar, to within a safe range.
To contact the reporters on this story: Angela Cullen in Frankfurt at acullen8@bloomberg.net ; Catherine Larkin in Washington at clarkin4@bloomberg.net
Last Updated: June 11, 2007 16:36 EDT
