MS Drug Tysabri Approved By FDA
By Stephanie Regina June 28, 2006
LI Chapter Hopeful, Cautious
The multiple sclerosis drug Tysabri, which has for the most part been a successful treatment for individuals who suffer from the disease, is expected to be made available next month despite the fact that it was pulled from the market last year after causing two fatalities. With some 7,000 people on Long Island who live with MS, President of the Long Island Chapter of the National Multiple Sclerosis Society Pamela Mastrota believes the return of Tysabri is good news.
“The Multiple Sclerosis Society is dedicated to providing choices,” she said, “and we’re pleased to give people another option to consider.” Locally, Stony Brook University Hospital participated in part of the study of the drug Tysabri.
Currently there are five drugs available for the treatment of MS, but Tysabri may be an option for individuals who do not find other drugs to be particularly effective. Because MS is not curable, individuals with the disease can receive treatments only to help control their symptoms. Symptoms vary from person to person and change over time, so that no particular treatment is considered most effective.
The FDA approved the drug after two clinical trials, which showed that in most individuals Tysabri delays the accumulation of physical disability and reduces the frequency of relapses in those with relapsing MS, according to documents from the National MS Society. During the trials, however, three patients out of 3,000 developed progressive multifocal leukoencephalopathy, or PML, which is caused by a virus and killed two of the three people who developed it while on Tysabri.
As one of the conditions for reintroducing Tysabri to the public, the drug will carry a “black box” warning on the label making users aware of the serious risks involved, according to the National MS Society. The drug will also include detailed protocol and be heavily restricted. Treatments will only be administered in clinics that have registered infusion centers where patients can receive the drug intravenously once a month. Those using the drug will be monitored closely and will not be permitted to use it in conjunction with any other MS drug.
Mastrota strongly suggests that those who consider using Tysabri discuss it extensively with their doctors before beginning the treatment. “That black box warning is a serious warning, which is why we strongly encourage patients to speak with their neurologists before making choices,” Mastrota said. “Everyone is different and it’s up to the individual to read patient materials and make careful decisions.”
James Blog of Huntington, who has had MS for 15 years, was part of the third phase of clinical trials. He received Tysabri treatments once a month for 18 months at Stony Brook University Hospital in combination with another MS drug called Avonex. He said he was virtually symptom-free while using Tysabri and believes people will benefit from its return. However, he’s not sure whether or not he’ll go back to using Tysabri himself.
“It’ll be a monotherapy, so I’ll have to talk to my neurologist before deciding,” he said. “The MS hasn’t disabled me much, so I have a choice whether or not to take the risk. But if I couldn’t walk very well, this would probably be a great thing.”
“We’re really thrilled that there’s another option,” Mastrota said, “but we can’t emphasize enough that people need to get educated, talk to their neurologist, and then make a decision.”
When the list of registered infusion centers for Tysabri becomes official, it will be available, along with other information about Tysabri, at the Long Island Chapter of the MS Society’s website at www.nationalmssociety.org.
http://www.zwire.com/site/news.cfm?newsid=16857237&BRD=1776&PAG=461&dept_id=6365&rfi=6
©Suffolk Life Newspapers 2006
LI Chapter Hopeful, Cautious
The multiple sclerosis drug Tysabri, which has for the most part been a successful treatment for individuals who suffer from the disease, is expected to be made available next month despite the fact that it was pulled from the market last year after causing two fatalities. With some 7,000 people on Long Island who live with MS, President of the Long Island Chapter of the National Multiple Sclerosis Society Pamela Mastrota believes the return of Tysabri is good news.
“The Multiple Sclerosis Society is dedicated to providing choices,” she said, “and we’re pleased to give people another option to consider.” Locally, Stony Brook University Hospital participated in part of the study of the drug Tysabri.
Currently there are five drugs available for the treatment of MS, but Tysabri may be an option for individuals who do not find other drugs to be particularly effective. Because MS is not curable, individuals with the disease can receive treatments only to help control their symptoms. Symptoms vary from person to person and change over time, so that no particular treatment is considered most effective.
The FDA approved the drug after two clinical trials, which showed that in most individuals Tysabri delays the accumulation of physical disability and reduces the frequency of relapses in those with relapsing MS, according to documents from the National MS Society. During the trials, however, three patients out of 3,000 developed progressive multifocal leukoencephalopathy, or PML, which is caused by a virus and killed two of the three people who developed it while on Tysabri.
As one of the conditions for reintroducing Tysabri to the public, the drug will carry a “black box” warning on the label making users aware of the serious risks involved, according to the National MS Society. The drug will also include detailed protocol and be heavily restricted. Treatments will only be administered in clinics that have registered infusion centers where patients can receive the drug intravenously once a month. Those using the drug will be monitored closely and will not be permitted to use it in conjunction with any other MS drug.
Mastrota strongly suggests that those who consider using Tysabri discuss it extensively with their doctors before beginning the treatment. “That black box warning is a serious warning, which is why we strongly encourage patients to speak with their neurologists before making choices,” Mastrota said. “Everyone is different and it’s up to the individual to read patient materials and make careful decisions.”
James Blog of Huntington, who has had MS for 15 years, was part of the third phase of clinical trials. He received Tysabri treatments once a month for 18 months at Stony Brook University Hospital in combination with another MS drug called Avonex. He said he was virtually symptom-free while using Tysabri and believes people will benefit from its return. However, he’s not sure whether or not he’ll go back to using Tysabri himself.
“It’ll be a monotherapy, so I’ll have to talk to my neurologist before deciding,” he said. “The MS hasn’t disabled me much, so I have a choice whether or not to take the risk. But if I couldn’t walk very well, this would probably be a great thing.”
“We’re really thrilled that there’s another option,” Mastrota said, “but we can’t emphasize enough that people need to get educated, talk to their neurologist, and then make a decision.”
When the list of registered infusion centers for Tysabri becomes official, it will be available, along with other information about Tysabri, at the Long Island Chapter of the MS Society’s website at www.nationalmssociety.org.
http://www.zwire.com/site/news.cfm?newsid=16857237&BRD=1776&PAG=461&dept_id=6365&rfi=6
©Suffolk Life Newspapers 2006
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