FDA Approves Relenza For Influenza

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UPDATE: FDA Approves Relenza For Influenza Prevention

Wednesday March 29, 1:02 PM EST 

(Updates with comments from FDA's Birnkrant starting in sixth paragraph and adds updated avian flu figures in fourth paragraph.)

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The Food and Drug Administration approved the antiviral drug Relenza Wednesday to prevent seasonal influenza in adults and children age five and older.

Relenza, made by GlaxoSmithKline PLC (GSK) (GSK), was previously approved to treat seasonal influenza in adults and children age five and older.

Relenza is the second drug approved for flu prevention. Roche Holding AG's (RHHBY) ( RHHBY) Tamiflu is also approved to treat and prevent seasonal influenza. Governments are stockpiling both drugs as treatments in the event of an influenza pandemic, or a new strain of influenza to which humans haven't been previously exposed.

Health officials are concerned that the H5N1 influenza strain, which is circulating mostly among poultry in Asia, the Middle East and Europe, could begin circulating among humans and spark the next flu pandemic. Since 2003, 186 humans have been infected with the H5N1 strain and 105 have died, according to the World Health Organization. It is believed the human cases were caught from close contact from infected birds and there is no evidence that the H5N1 virus has achieved human-to-human transmission.

"This approval is a welcome addition to the available defenses against the flu," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. However, agency officials said Relenza shouldn't be viewed as a substitute for an annual influenza vaccination and urged consumers to continue getting annual flu vaccinations.

Debra B. Birnkrant, M.D., director of FDA's division of anti-viral products, said the Relenza studies suggest it is effective at preventing the spread of the virus if, for example, a family begins treatment within a day and half of another family member becoming ill with the virus. Relenza would be administered for 10 days.

Dr. Birnkrant said the FDA can't say whether Relenza would be effective at preventing or treating a pandemic flu virus involving the H5N1 flue strain because the virus hasn't been tested in humans. However, she said laboratory and animal tests suggest Relenza might be effective at treating or preventing the spread of a pandemic flu virus.

The agency said Relenza's effectiveness at preventing the spread of seasonal flu was shown in four large-scale studies comparing the drug with a placebo, or a fake drug. The drug was studied in a total of 3,800 patients.

In two of the studies, the use of Relenza reduced the spread of influenza in the participating households that included participants age five and older. In both studies, the proportion of households that developed the flu was 19.0% for the placebo group and 4.1% for the Relenza group. Participating households were given Relenza or a placebo after one family member had been diagnosed with the flu to see if Relenza reduced the transmission of the virus to other family members.

The other studies were conducted in communities experiencing an influenza outbreak, one of which included a university setting. The university study showed the proportion of people who developed the flu 6.1% for the placebo group and 2.0% for the Relenza group. The second study enrolled people 12 to 94 years of age, with more than half of the study participants being older than age 65. The study also showed those receiving Relenza were less likely to develop the flu than those in the placebo group, the FDA said.

In all of the studies, the most common side effects reported during treatment with Relenza in adults and adolescents included a range of cold and flu-like symptoms such as headaches, diarrhea, nausea, vomiting, sinus infections and bronchitis. In children, the most common side effects were ear, nose and throat infections. Less common side effects included rash and allergic reaction, which was severe in some cases, the FDA said.

The FDA said Relenza isn't recommended for use in people with lung or airway diseases such as asthma or chronic obstructive pulmonary disease.

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Guests Members Profile Send Private Message Find Members Posts Add to Buddy List Guest Group	Post Options Post Reply Quote Guests Thanks(0) Quote Reply Topic: FDA Approves Relenza For Influenza Posted: March 29 2006 at 10:24am
	UPDATE: FDA Approves Relenza For Influenza Prevention Wednesday March 29, 1:02 PM EST (Updates with comments from FDA's Birnkrant starting in sixth paragraph and adds updated avian flu figures in fourth paragraph.) Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration approved the antiviral drug Relenza Wednesday to prevent seasonal influenza in adults and children age five and older. Relenza, made by GlaxoSmithKline PLC (GSK) (GSK), was previously approved to treat seasonal influenza in adults and children age five and older. Relenza is the second drug approved for flu prevention. Roche Holding AG's (RHHBY) ( RHHBY) Tamiflu is also approved to treat and prevent seasonal influenza. Governments are stockpiling both drugs as treatments in the event of an influenza pandemic, or a new strain of influenza to which humans haven't been previously exposed. Health officials are concerned that the H5N1 influenza strain, which is circulating mostly among poultry in Asia, the Middle East and Europe, could begin circulating among humans and spark the next flu pandemic. Since 2003, 186 humans have been infected with the H5N1 strain and 105 have died, according to the World Health Organization. It is believed the human cases were caught from close contact from infected birds and there is no evidence that the H5N1 virus has achieved human-to-human transmission. "This approval is a welcome addition to the available defenses against the flu," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. However, agency officials said Relenza shouldn't be viewed as a substitute for an annual influenza vaccination and urged consumers to continue getting annual flu vaccinations. Debra B. Birnkrant, M.D., director of FDA's division of anti-viral products, said the Relenza studies suggest it is effective at preventing the spread of the virus if, for example, a family begins treatment within a day and half of another family member becoming ill with the virus. Relenza would be administered for 10 days. Dr. Birnkrant said the FDA can't say whether Relenza would be effective at preventing or treating a pandemic flu virus involving the H5N1 flue strain because the virus hasn't been tested in humans. However, she said laboratory and animal tests suggest Relenza might be effective at treating or preventing the spread of a pandemic flu virus. The agency said Relenza's effectiveness at preventing the spread of seasonal flu was shown in four large-scale studies comparing the drug with a placebo, or a fake drug. The drug was studied in a total of 3,800 patients. In two of the studies, the use of Relenza reduced the spread of influenza in the participating households that included participants age five and older. In both studies, the proportion of households that developed the flu was 19.0% for the placebo group and 4.1% for the Relenza group. Participating households were given Relenza or a placebo after one family member had been diagnosed with the flu to see if Relenza reduced the transmission of the virus to other family members. The other studies were conducted in communities experiencing an influenza outbreak, one of which included a university setting. The university study showed the proportion of people who developed the flu 6.1% for the placebo group and 2.0% for the Relenza group. The second study enrolled people 12 to 94 years of age, with more than half of the study participants being older than age 65. The study also showed those receiving Relenza were less likely to develop the flu than those in the placebo group, the FDA said. In all of the studies, the most common side effects reported during treatment with Relenza in adults and adolescents included a range of cold and flu-like symptoms such as headaches, diarrhea, nausea, vomiting, sinus infections and bronchitis. In children, the most common side effects were ear, nose and throat infections. Less common side effects included rash and allergic reaction, which was severe in some cases, the FDA said. The FDA said Relenza isn't recommended for use in people with lung or airway diseases such as asthma or chronic obstructive pulmonary disease. http://money.iwon.com/jsp/nw/nwdt_rt_top.jsp?cat=TOPBIZ&src=704&feed=dji§ion=news&news_id=dji-00077520060329&date=20060329&alias=/alias/money/cm/nw