FDA Panel Backs Seroquel To Treat Schizophrenia In Teens >AZN

A Food and Drug Administration panel said Wednesday Seroquel was “acceptably safe” and effective to treat schizophrenia in adolescents.

Seroquel, made by AstraZeneca PLC (AZN) is currently approved to treat schizophrenia and bipolar disorder in adults. The company is seeking FDA approval to market the drug to treat schizophrenia in adolescents ages 13 to 17 and bipolar disorder in children ages 10 to 17.

Seroquel is AstraZeneca’s second-best selling drug with $4.45 billion in sales in 2008. Doctors already use the drug to treat children and adolescents, so it is unclear how receiving FDA approval to market the drug for use in younger patients would add to annual sales figures. The panel overwhelmingly voted that Seroquel was “acceptably safe” and effective.

Along with Seroquel, the FDA is considering Eli Lilly and Co.‘s (LLY) Zyprexa to treat bipolar disorder and schizophrenia in adolescents and Pfizer Inc.‘s (PFE) Geodon to treat bipolar disorder in children ages 10 to 17. Lilly is seeking so-called second-line status for Zxprexa, which means other drugs should be tried first.

An FDA panel of outside medical experts is discussing each drug and voting Wednesday whether it thinks the products are safe and effective for pediatric patients. The panel overwhelmingly voted that Seroquel was “acceptably safe” and effective.

The outcome of the votes will amount to a recommendation about whether the panel thinks the FDA should expand approval for the products. The FDA usually follows its panels’ advice but is not required to.

“There are significant risks associated with these drugs,” said Thomas Laughren, director of the FDA’s psychiatric product division.

However, he noted there are just two other drugs approved for pediatric patients and said schizophrenia and bipolar disorder are “serious” diseases that need additional treatment options because patients respond differently to each drug. Risperdal, by a unit of Johnson & Johnson (JNJ), and Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co., are approved to treat pediatric patients.

U.S. Food and Drug Administration staff said in memos released Friday that the three drugs were effective at treating the disorders in children and adolescents, but they carry “significant risks” that included sedation and weight gain.

The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.

The FDA asked each company to look at which side effects were more commonly seen in children compared to the adults who were studied in clinical trials.

AstraZeneca said side effects that occurred more frequently in children compared to adults on Seroquel included increases in blood pressure and increased appetite.

Schizophrenia afflicts about 1% of Americans. According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don’t hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is also a cause of suicide and is typically diagnosed in a person’s late teens or 20s.

Bipolar disorder, also known as manic-depressive illness, is believed to affect about 1% to 3% of the population, and is characterized by unusual shifts in mood, energy and activity levels. There is evidence that bipolar disorder in children is more severe than typically seen in adults.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; .(JavaScript must be enabled to view this email address)

(Updates with panel vote on bipolar disorder, starting in first paragraph.)

  By Jennifer Corbett Dooren
  Of DOW JONES NEWSWIRES
——————————

WASHINGTON (Dow Jones)—A Food and Drug Administration panel said Wednesday that Seroquel is “acceptably safe” and effective to treat children and adolescents with schizophrenia or bipolar disorder.

Seroquel, made by AstraZeneca PLC (AZN) is currently approved to treat schizophrenia and bipolar disorder in adults. The company is seeking FDA approval to market the drug to treat schizophrenia in adolescents ages 13 to 17 and bipolar disorder in children ages 10 to 17.

Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008. Doctors already use the drug to treat children and adolescents, so it is unclear how receiving FDA approval to market the drug for use in younger patients would add to annual sales figures. The panel overwhelmingly voted that Seroquel was “acceptably safe” and effective for schizophrenia. The panel also said the product was “acceptably safe” for use in pediatric patients, with 13 panel members stating that the drug was safe and five panel members abstaining. Some who abstained said they were concerned that the definition of what constitutes bipolar disorder wasn’t well-defined in younger patients.

Along with Seroquel, the FDA is considering Eli Lilly and Co.‘s (LLY) Zyprexa to treat bipolar disorder and schizophrenia in adolescents and Pfizer Inc.‘s (PFE) Geodon to treat bipolar disorder in children ages 10 to 17. Lilly is seeking so-called second-line status for Zyprexa, which means other drugs should be tried first.

An FDA panel of outside medical experts is discussing each drug and voting Wednesday whether it thinks the products are safe and effective for pediatric patients. The panel overwhelmingly voted that Seroquel was “acceptably safe” and effective.

The outcome of the votes will amount to a recommendation about whether the panel thinks the FDA should expand approval for the products. The FDA usually follows its panels’ advice but is not required to.

“There are significant risks associated with these drugs,” said Thomas Laughren, director of the FDA’s psychiatric product division.

However, he noted there are just two other drugs approved for pediatric patients and said schizophrenia and bipolar disorder are “serious” diseases that need additional treatment options because patients respond differently to each drug. Risperdal, by a unit of Johnson & Johnson (JNJ), and Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co., are approved to treat pediatric patients.

U.S. Food and Drug Administration staff said in memos released Friday that the three drugs were effective at treating the disorders in children and adolescents, but they carry “significant risks” that included sedation and weight gain.

The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.

The FDA asked each company to look at which side effects were more commonly seen in children compared to the adults who were studied in clinical trials.

AstraZeneca said side effects that occurred more frequently in children compared to adults on Seroquel included increases in blood pressure and increased appetite.

Schizophrenia afflicts about 1% of Americans. According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don’t hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is also a cause of suicide and is typically diagnosed in a person’s late teens or 20s.

Bipolar disorder, also known as manic-depressive illness, is believed to affect about 1% to 3% of the population, and is characterized by unusual shifts in mood, energy and activity levels. There is evidence that bipolar disorder in children is more severe than typically seen in adults.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; .(JavaScript must be enabled to view this email address)

(Updates with panel vote on Pfizer’s (PFE) Geodon and company statements starting in second graph.)

  By Jennifer Corbett Dooren
  Of DOW JONES NEWSWIRES
——————
WASHINGTON (Dow Jones)—A Food and Drug Administration panel said Wednesday that Seroquel is “acceptably safe” and effective to treat children and adolescents with schizophrenia or bipolar disorder.

Seroquel, made by AstraZeneca PLC (AZN) is currently approved to treat schizophrenia and bipolar disorder in adults. The company is seeking FDA approval to market the drug to treat schizophrenia in adolescents ages 13 to 17 and bipolar disorder in children ages 10 to 17. The panel said it thought Pfizer Inc.‘s (PFE) Geodon was effective for use in treating bipolar disorder in children ages 10 to 17 but split on whether the drug was safe. Many panel members said they were concerned about a high number of patients who didn’t complete clinical studies of the product, making its safety difficult to access.

In a statement Pfizer said it would address any outstanding questions with the FDA.

Along with Seroquel and Geodon, the FDA is considering Eli Lilly and Co.‘s (LLY) Zyprexa to treat bipolar disorder and schizophrenia in adolescents. Lilly is seeking so-called second-line status for Zyprexa, which means other drugs should be tried first.

An FDA panel of outside medical experts is discussing each drug and voting Wednesday whether it thinks the products are safe and effective for pediatric patients.

The outcome of the votes will amount to a recommendation about whether the panel thinks the FDA should expand approval for the products. The FDA usually follows its panels’ advice but isn’t required to.

“There are significant risks associated with these drugs,” said Thomas Laughren, director of the FDA’s psychiatric product division.

However, he noted there are just two other drugs approved for pediatric patients and said schizophrenia and bipolar disorder are “serious” diseases that need additional treatment options because patients respond differently to each drug. Risperdal, by a unit of Johnson & Johnson (JNJ), and Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co., are approved to treat pediatric patients.

Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008. Doctors already use the drug to treat children and adolescents, so it is unclear how receiving FDA approval to market the drug for use in younger patients would add to annual sales figures. The panel overwhelmingly voted that Seroquel was “acceptably safe” and effective for schizophrenia. The panel also said the product was “acceptably safe” for use in pediatric patients, with 13 panel members stating that the drug was safe and five panel members abstaining. Some who abstained said they were concerned that the definition of what constitutes bipolar disorder wasn’t well defined in younger patients.

FDA staff said in memos released Friday that the three drugs were effective at treating the disorders in children and adolescents, but they carry “significant risks” that included sedation and weight gain.

The concern with weight gain seen with most antipsychotic drugs is whether it causes additional problems such as diabetes and cardiovascular disease.

The FDA asked each company to look at which side effects were more commonly seen in children compared to the adults who were studied in clinical trials.

AstraZeneca said side effects that occurred more frequently in children compared to adults on Seroquel included increases in blood pressure and increased appetite while Pfizer said children taking Geodon were more likely than adults to report feeling sleepy, or sedated.

Lilly said clinical studies of Zyprexa showed the product was associated with greater weight gain and changes in blood lipid parameters than seen in adults using the product.

Schizophrenia afflicts about 1% of Americans. According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don’t hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is also a cause of suicide and is typically diagnosed in a person’s late teens or 20s.

Bipolar disorder, also known as manic-depressive illness, is believed to affect about 1% to 3% of the population, and is characterized by unusual shifts in mood, energy and activity levels. There is evidence that bipolar disorder in children is more severe than typically seen in adults.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; .(JavaScript must be enabled to view this email address)

(Updates with panel vote on Lilly’s Zyprexa starting in second paragraph and adds additional details throughout)

  By Jennifer Corbett Dooren
  Of DOW JONES NEWSWIRES
—————-

WASHINGTON (Dow Jones)—A Food and Drug Administration panel Wednesday backed the use of AstraZeneca PLC’s (AZN) Seroquel in children and adolescents, saying the antipsychotic was “acceptably safe” and effective to treat schizophrenia and bipolar disorder.

The panel said another drug, Zyprexa, by Eli Lilly & Co. (LLY), could also be used to treat both disorders in certain pediatric patients, but only after other drugs were tried first because of concerns about significant weight gain in many patients. Officials from Eli Lilly acknowledged the weight problem during the meeting and agreed with recommendations that other drugs be tried first.

The panel said it thought Pfizer Inc.‘s (PFE) Geodon was effective for use in treating bipolar disorder in children ages 10 to 17, but split on whether the drug was safe.

All three products are currently approved for use in adults but the companies are all seeking FDA approval to market the products to younger patients.

Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008 while Zyprexa is Lilly’s top-selling drug with $4.7 billion annual sales in 2008. Doctors already use the products to treat children and adolescents, so it is unclear how receiving FDA approval to market the drug for use in younger patients would add to annual sales figures.

The FDA brought the drugs before an FDA panel of outside medical experts to discuss “significant risks” seen with the drugs such as weight gain, sedation and changes in other parameters like cholesterol and blood glucose, or blood-sugar levels. The concern is whether such risks would eventually cause other health problems such as diabetes and cardiovascular disease.

Thomas Laughren, director of the FDA’s psychiatric product division, said schizophrenia and bipolar disorder are “serious” diseases that need additional treatment options. Risperdal, by a unit of Johnson & Johnson (JNJ), and Abilify, by Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co., are currently approved to treat pediatric patients.

On Pfizer’s Geodon, many panel members said they were concerned about a high number of patients who didn’t complete clinical studies of the product, making its safety difficult to access.

In a statement, Pfizer said it would address any outstanding questions with the FDA.

Specifically, AstraZeneca is seeking FDA approval to market Seroquel in adolescents with schizophrenia ages 13 to 17 and bipolar disorder in patients ages 10 to 17. Pfizer is seeking FDA approval for Geodon to treat bipolar disorder in children ages 10 to 17.

Lilly is seeking FDA approval for Zyprexa in patients ages 13 to 17 with schizophrenia or bipolar disorder but only after other drugs are tried first. Schizophrenia afflicts about 1% of Americans.

According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don’t hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is also a cause of suicide and is typically diagnosed in a person’s late teens or 20s.

Bipolar disorder, also known as manic-depressive illness, is believed to affect about 1% to 3% of the population, and is characterized by unusual shifts in mood, energy and activity levels. There is evidence that bipolar disorder in children is more severe than typically seen in adults.

  -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; .(JavaScript must be enabled to view this email address)