FDA says Tysabri can be given to some MS patients
Last Update: 3:20 PM ET Feb 15, 2006
(Updates with new information about FDA considering lifting of other clinical trials involving proposed MS drug by GlaxoSmithKline in seventh paragraph.)
WASHINGTON (MarketWatch) -- The Food and Drug Administration said Wednesday that Biogen Idec Inc. (BIIB) and Elan Corp. (ELN) can begin giving their drug Tysabri to some patients with multiple sclerosis.
The FDA said the companies can make the drug available to patients who were receiving the drug as part of preclinical studies.
The companies voluntarily removed Tysabri from the U.S. market last February after two patients developed a rare brain disorder and one died. A third patient was later discovered to have the disorder, known as progressive multifocal leukoencephalopathy, or PML, in studies of the drug for Crohn's disease, an intestinal illness. No additional cases of the disorder have been found.
On March 7, the FDA will convene an outside panel of medical experts to make recommendations about whether Tysabri should be allowed to return to the broader market. The FDA is expected to make a final decision by the end of March.
In a posting to its Web site on Wednesday, the FDA said it "remains very concerned about the potential for PML" associated with Tysabri. "However, the currently available information are not adequate to clearly define the level of risk or the exact circumstances when this risk occurs."
The FDA also said existing data on Tysabri show the drug "is a very effective product and multiple sclerosis is a very devastating disease." The FDA also said it would consider lifting holds on other MS clinical trials involving drug compounds similar to Tysabri if requested by drug makers. The FDA placed a hold on the trials, including one involving a proposed drug by GlaxoSmithKline PLC (GSK), after Tysabri was removed from the market.
If Tysabri were allowed to be returned to the market, it will likely contain new warnings about the possibility of PML and restrictions. The FDA first approved the drug in November 2004 to treat MS, a progressive disease that affects the spinal cord and brain and involves damage to nerves that control muscles and vision. The drug was on the market only for a short time before being pulled last year.
Biogen and Elan filed for permission to return Tysabri to the market in September. The FDA granted so-called priority review status to the application, which is usually reserved for drugs the agency deems would be a "significant improvement" compared to existing treatments if the product were to be approved. It cuts about four months off of the typical 10-month review period for a drug.
-Contact: 201-938-5400
http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B9AFEEFFB%2DCD14%2D445C%2D83B4%2DF354ABBC0E0A%7D&siteid=google&dist=
(Updates with new information about FDA considering lifting of other clinical trials involving proposed MS drug by GlaxoSmithKline in seventh paragraph.)
WASHINGTON (MarketWatch) -- The Food and Drug Administration said Wednesday that Biogen Idec Inc. (BIIB) and Elan Corp. (ELN) can begin giving their drug Tysabri to some patients with multiple sclerosis.
The FDA said the companies can make the drug available to patients who were receiving the drug as part of preclinical studies.
The companies voluntarily removed Tysabri from the U.S. market last February after two patients developed a rare brain disorder and one died. A third patient was later discovered to have the disorder, known as progressive multifocal leukoencephalopathy, or PML, in studies of the drug for Crohn's disease, an intestinal illness. No additional cases of the disorder have been found.
On March 7, the FDA will convene an outside panel of medical experts to make recommendations about whether Tysabri should be allowed to return to the broader market. The FDA is expected to make a final decision by the end of March.
In a posting to its Web site on Wednesday, the FDA said it "remains very concerned about the potential for PML" associated with Tysabri. "However, the currently available information are not adequate to clearly define the level of risk or the exact circumstances when this risk occurs."
The FDA also said existing data on Tysabri show the drug "is a very effective product and multiple sclerosis is a very devastating disease." The FDA also said it would consider lifting holds on other MS clinical trials involving drug compounds similar to Tysabri if requested by drug makers. The FDA placed a hold on the trials, including one involving a proposed drug by GlaxoSmithKline PLC (GSK), after Tysabri was removed from the market.
If Tysabri were allowed to be returned to the market, it will likely contain new warnings about the possibility of PML and restrictions. The FDA first approved the drug in November 2004 to treat MS, a progressive disease that affects the spinal cord and brain and involves damage to nerves that control muscles and vision. The drug was on the market only for a short time before being pulled last year.
Biogen and Elan filed for permission to return Tysabri to the market in September. The FDA granted so-called priority review status to the application, which is usually reserved for drugs the agency deems would be a "significant improvement" compared to existing treatments if the product were to be approved. It cuts about four months off of the typical 10-month review period for a drug.
-Contact: 201-938-5400
http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B9AFEEFFB%2DCD14%2D445C%2D83B4%2DF354ABBC0E0A%7D&siteid=google&dist=
posted by Bill at 7:20 AM
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