Tysabri Reapproved!
6/06 by Laurie LongUpdated 6/07
On June 5th, 2006, the Food and Drug Administration (FDA) approved the reintroduction of the drug Tysabri for relapsing forms of MS. On July 18, 2006, Biogen Idec and Elan Pharmaceuticals launched Tysabri® (natalizumab) in the U.S.
Tysabri was originally given accelerated approval in November of 2004 by the FDA to treat relapsing forms of multiple sclerosis. The approval was granted following a priority review based on one-year results from two Phase III studies. However, after three patients developed PML (progressive multifocal leukoencephalopathy) of which two died, the drug was withdrawn.
PML is a rare, progressive neurologic disease of the brain. There is no known effective treatment for PML. Although the relationship between Tysabri and PML was not known, because of the serious and often fatal nature of PML the FDA concurred with the company that the drug be voluntarily withdrawn from marketing and that the use of Tysabri in clinical trials be suspended until more is known.
Since then Tysabri has undergone additional testing to determine its potential versus the possible risks involved with the treatment.
Tysabri is now available to all those who complete the TOUCH Prescribing Program, a new risk management program. This program is designed to inform physicians and patients of the benefits and risks of Tysabri treatment and to minimize the risk of PML.
The TOUCH Prescribing Program includes:
- Revised labeling with prominent warning about the risk of PML and also warnings against use for anyone with chronic immunosuppresant or immunomodulatory therapies, or those who are immunocompromised.
- Mandatory enrollment for all prescribers, pharmacies, infusion centers and Tysabri patients.
- Distribution only to authorized infusion centers.
- Mandatory FDA-reviewed educational packets for patients and physicians.
- Ongoing assessment of PML risk and overall safety. A 5,000 patient observational study over five years.
The FDA has recommended that Tysabri only be used for patients who have not responded well to other MS treatments. It should be used as a monotherapy – not to be used with other immune system modifying drugs. Tysabri is given by intravenous infusion every 4 weeks and will be given only at authorized infusion centers.
Biogen estimates that Tysabri, returned to the market July 18th, should be available to individuals in August. Whether insurance companies will cover the drug is another question.
One insurance company, Humana Inc., says it will cover the drug if patients meet the criteria laid out by the FDA. Humana patients on Medicare who qualify will probably pay between 20 – 25% of the total cost.
According to a statement by Elan, who is setting the price for Tysabri, that cost will rise 21% from its previous price. The yearly price for Tysabri will now be $28,400, making it the most expensive MS drug on the market.
So why are people willing to risk possible death (a one in one thousand chance, according to some FDA doctors) and pay such a price for this drug? The AFFIRM study showed that treatment with Tysabri reduced the annual relapse rate for MS by 67%. That’s twice the effectiveness of other MS drugs currently on the market. Tysabri treatment also showed sustained reductions in brain lesion activity measured by MRIs.
For many MS sufferers, that’s more than enough reason to jump through all the hoops and pay the huge price. Pam Thorp had two treatments with Tysabri before it was pulled from the market, and noticed an improvement in her motor skills even in so short a time. “I was just devastated when they took it off the market,” she said. “To me, it was well worth a shot.”
If you are interested in starting Tysabri, consult with your neurologist, and check with your insurance company to see if they cover the drug.
For further information about Tysabri, call the MS Active Source information line at: 1-800-456-2255, or go to the Biogen Idec's Tysabri site at www.Tysabri.com
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Bibliography & References
“Questions and Answers on Natalizumab (marketed as Tysabri)”. US Food and Drug Administration Center for Drug Evaluation and Research. 3/1/05. http://www.fda.gov/cder/drug/infopage/
natalizumab/natalizumabQA_2_2005.htm
“Doctors Seen as Key to Tysabri Success”. Los Angeles Times & Associated Press. 5/16/06. http://www.latimes.com/business/la-fi-tysabri16may16,0,4680711.story
Dixon, Kim and Krauskopf, Lewis. “Next hurdle for Biogen’s Tysabri MS drug: HMOs”. Reuters 6/6/06. http://today.reuters.com/business/newsArticle.aspx?type=ousiv&
storyID=2006-06-06T195534Z_01_N06387387_RTRIDST_0_
BUSINESSPRO-TYSABRI-DC.XML
“Elan Rises As Price Raised on Tysabri”. Associated Press Business News. 6/9/06.
“Price of Tysabri to rise when it comes to market”. The Boston Globe. 6/10/06. http://www.boston.com/business/articles/2006/06/10/
price_of_tysabri_to_rise_when_it_comes_to_market/
D’Angelo, Victor. “Tysabri has been reintroduced and should be available July to help fight multiple sclerosis”. Worldfitness News, CA. 6/5/06. http://news.worldfitness.ca/news/060506/
TYSABRIReintroducedAndApprovedByFDA.php
“Tysabri FDA Approval Under Special Distribution Program for Multiple Sclerosis”. Medical News Today. 6/5/06. http://www.medicalnewstoday.com/healthnews.php?newsid=44581
“Relapsing multiple sclerosis: FDA has approved the reintroduction of Tysabri”. MedicineNews.net & Biogen. 6/5/06. http://www.xagena.it/news/medicinenews_net_news/
e3efff5eac2e06e30b5d2073b765876b.html
“FDA Approves Tysabri’s Return to Market for Relapsing MS”. National MS Society Research/Clinical Update. 6/5/06. http://www.nationalmssociety.org/tysabri_2006approval.asp
“New Tysabri Data Demonstrate Significant Effects on Health-Related Quality of Life Measures in Multiple Sclerosis Patients”. Medical News Today. 4/8/06. http://www.medicalnewstoday.com/medicalnews.php?newsid=41270
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