Natalizumab Update

" For most people with multiples or medication is important to help slow the progression of the to. In early 2000 clinical trial evidence growing -- in new drug might prove more restrictive in the medicines during currently available. There weren't too large pro active clinical trials you and Natalie man -- a renowned opera. And at the end of those trials -- indications were coming off factor in years."

" It was quite clear that act robbery was indeed the next generate an aunt and the better. People ask you were survey and 68 per cent reduction and exacerbate and rate and -- twice factor in any of the interference or a and 42 per cent reduction in the probability."

" Odd going on and sustained moral. Impairment as measured by IRL."

" The drug was approved by the FDA used in November 2000 war. But within three months startling news that the manufacturer. Following discussions with the FDA to voluntarily withdraw Natalie grant from the market. The drug was approved in May 2004. But in February of 2005. There are the two reports and these were reported in the manufacture of an analyst Matt. And a very serious brain infection. And this -- a very rare brain infection that we typically don't see it at all. It's an intact and that is called progressive multiple local loop on a lot -- that's quite -- big now also week all by nationals and now. Manufacture and UST quickly began an investigation into the two. And Natalie as. And in a third in a person with crohn's disease who also use Natalie and how."

" In concert with a number of worldwide experts and progress of multiple political and a lot technique. And and cooperate and where the yeah. The manufacturer. Reviewed in particular like every single person who had ever been given. Metals and advertised robbery in order to determine -- there were any other cases out there. And -- the better part of a year. The investigators found no working EM out. They were three -- among more than 3000 people who were treated with Natalie and -- Surveillance was complete the question turned to well -- drug come back out on the market again. It was fairly clearly established that the risk of him now what is in the area one and 2000 demonstrations have been created. On the over an 824 month period. And what is that reasonable -- allowed back out on the market or was that too risky. And and immediately. Bring -- 2000 and sent an Independent. Advisory panel was brought together. To review with the result of the whole safety inquiry that had been conducted after the previous sixteen month. Bad advisory committee voted unanimously. I had to read and reduce the drug but in a more controlled way with more say it error in what's called any -- Procedure that would allow -- to write down by any and her. And then that would occur or safety concern that would occur going forwards. Several safeguards were put into place when drug what is reintroduced and they really center around system. Is under control and drug being dispensed. In his system to monitor four cases -- him now. In order for patients who receive cyber. First ball prescribing and must be specifically train to. And in the investor. It's appropriate and and the safety concerns that had been identified. To. Accurately. Deeper and didn't mention the -- and sent her -- our our growth through rigorous training -- where they once again are alerted to the -- and penitence and drug and what to look for -- I am now back."

" Third safeguards to ensure that the drug be prescribed only for that type of -- in which it was test it relapse and forms of the disease. Doctors who prescribe -- that without any other type of immune suppressing therapy. Because there may be a compound act increasing the chances of developing -- Very important aspect about current treatment with -- and that is that it is to be used only in Amman where it should not be combined to another and manage the new rules call for the use of nationalism that. We're patience has failed and other medications. But there remains a ruling -- guidelines for doctors to use the drug initially in and very aggressive case is about an. And so now learning is that it is generally indicated for Haitians who have not responded or not tolerated the standard injectable -- And that leaves open the option for clinicians to use it as a first line therapy -- we don't feel comparable. Waiting in the six or twelve months this year and injectable fair in war. Doctors say it was important to reevaluate the safety of Natalie and after the but the consensus. Seems to be that its reintroduction. Gives doctors and patients an important option in treating disease that often become debilitating."

" nobody wants you get ya one -- and can't and -- potentially fatal. Viral infection."

" However. When balance again and to lead to see how management and that neighbors spent ethically and clearly shifts in her."

" Of allowing him in position to make a choice."

" I'm depending upon their perception of the relative --"