Tysabri has retaken its place alongside Novantrone, Copaxone, Avonex, Betaseron and Rebif as the approved therapies for multiple sclerosis disease modification. Elan and Biogen today announced that Tysabri (natalizumab) is now available for administration in the United States as well as several European countries.
This (hopefully) marks the end of Tysabri's epic and volatile journey from lab to market, and the beginning of patients benefitting from a potent, if controversial, new weapon against multiple sclerosis progression and disability...
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...The drug had been cleared last month to return to market pending the implementation of a far-reaching risk management program dubbed TOUCH. The charter of TOUCH is to ensure that the drug distribution and administration is carefully monitored such that any adverse effects, particularly those relating to PML-- the devastating brain disease that developed in 3 Tysabri-exposed patients when first introduced to the market nearly two years ago.
Because of the as-yet mysterious link to PML, Tysabri is being touted as a second-line therapy, to be used when other medications fail to work, or are not tolerated by the patient. With time, the criteria and odds of a Tysabri-dosed patient developing PML will become more clear and, if unexpected cases do not arise, the drug can be reclassified as first-line therapy.
"Under the TOUCH Prescribing Programme only prescribers, infusion centres and pharmacies associated with infusion centres registered in the TOUCH programme are able to prescribe, infuse or distribute Tysabri," said Elan. Further, they have contracted with 12 specialty pharmacies to handle these duties.
Source: http://elan.com/News/full.asp?ID=885261
