US FDA staff cite safety concern with Lilly drug Reuters Monday February 4 2008

US FDA staff cite safety concern with Lilly drug Reuters Monday February 4 2008

Joined: April 1st, 2004, 4:56 pm

February 4th, 2008, 2:48 pm #1

<DIV id=article-header>
<H1 class=article-no-standfirst id=heading-alone>US FDA staff cite safety concern with Lilly drug</H1></DIV>
<DIV id=content>
<UL class="article-attributes no-pic">
<LI class=publication>Reuters
<LI class=date>Monday February 4 2008 </LI>[/list]
<DIV>WASHINGTON, Feb 4 (Reuters) - Excessive sedation is a "serious safety concern" with an experimental, long-acting form of Eli Lilly and Co's blockbuster Zyprexa schizophrenia drug, U.S. drug reviewers said in an analysis released on Monday.</DIV>
<DIV>Food and Drug Administration staff said the injectable formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia.</DIV>
<DIV>The analysis was released ahead of a Wednesday meeting by a panel of outside advisers who will review the drug. (Reporting by Lisa Richwine, editing by Gerald E. McCormick) </DIV></DIV>
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February 4th, 2008, 2:49 pm #2

Excessive sedation is a "serious safety concern" with an experimental, long-acting form of Eli Lilly and Co's blockbuster Zyprexa schizophrenia drug,
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February 4th, 2008, 2:51 pm #3

Anesthetic method and composition
<SPAN class=authors><FONT size=2>US Patent Issued on </FONT><FONT color=#333333 size=2>October 26, 1999</FONT></SPAN>

&nbsp;

<FONT size=6>http://www.patentstorm.us/patents/59729 ... html</FONT>
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Joined: April 1st, 2004, 4:56 pm

February 4th, 2008, 2:52 pm #4

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February 4th, 2008, 2:53 pm #5

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February 4th, 2008, 2:56 pm #6


From the <FONT color=#b54141>Indy Star</FONT>:&nbsp;

<!-- PHOTO & FACTBOX --><!-- ARTICLE SIDEBAR -->The agency’s panel of psychiatric drug advisers will meet Feb. 6 to assess Zyprexa Adhera, an injectable version of the company’s best-selling drug, which accounted for a quarter of Lilly’s sales last year.


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Joined: April 1st, 2004, 4:56 pm

February 4th, 2008, 3:41 pm #7

<DIV id=article-header>
<H1 class=article-no-standfirst id=heading-alone>US FDA staff cite safety concern with Lilly drug</H1></DIV>
<DIV id=content>
<UL class="article-attributes no-pic">
<LI class=publication>Reuters
<LI class=date>Monday February 4 2008 </LI>[/list]
<DIV>WASHINGTON, Feb 4 (Reuters) - Excessive sedation is a "serious safety concern" with an experimental, long-acting form of Eli Lilly and Co's blockbuster Zyprexa schizophrenia drug, U.S. drug reviewers said in an analysis released on Monday.</DIV>
<DIV>Food and Drug Administration staff said the injectable formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia.</DIV>
<DIV>The analysis was released ahead of a Wednesday meeting by a panel of outside advisers who will review the drug. (Reporting by Lisa Richwine, editing by Gerald E. McCormick) </DIV></DIV>
<SPAN class=dateline>WASHINGTON</SPAN>
Federal regulators on Monday said a longer-lasting version of Eli Lilly's schizophrenia drug, Zyprexa, appears effective, though a small number of patients experienced excessive sleepiness.

The Food and Drug Administration posted its review of Zyprexa Adhera ahead of a Wednesday panel meeting, where psychiatric drug advisers will vote on whether the drug is safe and effective.

Zyprexa is currently available as a once-daily pill to treat schizophrenia and bipolar disorder. The new formulation is injected into the muscle and is designed to last two to four weeks.

FDA will ask its outside experts to assess incidents of "profound sedation," seen in about one percent of patients injected with the drug. Most of the reports of sedation occurred one to three hours after injection.

According to FDA, the side effect is unique to injectable Zyprexa and may require warning labeling to bring it to the attention of doctors and physicians. Based on draft questions posted to its Web site, FDA will ask its advisers whether the drug requires a "black box" warning, the most serious a drug can carry.

For its part, Lilly said the sedation side effect is common to both traditional Zyprexa and the new version. According to a company analysis posted online Monday, there were "no differences in the incidence or timing of sedation" events between Zyprexa and Zyprexa Adhera.

The company's scientists speculate that the drowsiness was caused by doctors incorrectly injecting the drug directly into the bloodstream, instead of into the muscle. Lilly said when the drug is injected appropriately it dissolves into the body over days and weeks, but when it is injected into the bloodstream it is absorbed over a few hours.

Sales of Zyprexa were $1.67 billion in the last quarter of 2007.

Shares of Eli Lilly & Co. fell 16 cents Monday to $51.50
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February 4th, 2008, 3:42 pm #8


The company's scientists speculate that the drowsiness was caused by doctors incorrectly injecting the drug directly into the bloodstream, instead of into the muscle. Lilly said when the drug is injected appropriately it dissolves into the body over days and weeks, but when it is injected into the bloodstream it is absorbed over a few hours.

Sales of Zyprexa were $1.67 billion in the last quarter of 2007.
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Joined: April 1st, 2004, 4:56 pm

February 4th, 2008, 3:43 pm #9

&nbsp;

&nbsp;
&nbsp;
Anesthetic method and composition
<SPAN class=authors><FONT size=2>US Patent Issued on </FONT><FONT color=#333333 size=2>October 26, 1999</FONT></SPAN>

&nbsp;

<FONT size=6>http://www.patentstorm.us/patents/59729 ... html</FONT>

&nbsp;

&nbsp;
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