FDA Reversal--Lemtrada approved

[MSSpouse]

Happy-making for MSers and shareholders alike, no doubt.
http://www.bostonglobe.com/business/...7JP/story.html

[ActiveMSers]

Thanks for the post, MS Spouse! This is fantastic news. The 12-year study data is powerful and offers another critical treatment option for multiple sclerosis:

http://activemsers.wssnoc.net/showthread.php?t=1619

[ActiveMSers]

MS researchers at the renowned Barts and the London just blogged this, and are very excited over its potential:

"How and why did the FDA get it so wrong? They have now reversed their decision and licensed alemtuzumab for the treatment of MS. Please see Genzyme's press release below. Good news for MSers in the US is that they now have access to alemtuzumab to treat MS, but only as a 3rd line therapy. This may, or may not, end health tourism from the US to other countries for alemtuzumab induction therapy. I suspect that a lot of MSers in the US will be envious of the European label that allows 1st-line usage that maximises the benefits of alemtuzumab therapy. Once you have failed 1, 2 or 3 other DMTs you will have accumulated a lot of damage, which may limit alemtuzumab's effectiveness. Alemtuzumab is one of the most effective MS therapies we have and the only induction therapy on the table. I rate its clinical efficacy as being in the same zone as natalizumab and bone marrow transplantation (not licensed as a MS treatment). Alemtuzumab offers the advantage of being an induction therapy over natalizumab and it is safer than BMT. However, alemtuzumab comes with its own relatively unique safety profile that makes most neurologists, and the FDA, label it as too risky for 1st-line use. I think we need ask ourselves who should be taking on the risks of alemtuzumab as a treatment for MS; regulators, neurologists or the MSers themselves? I personally believe that if someone with active MS understands their disease and the risks and benefits of the various treatment options on the table, who am I to deny them treatment with alemtuzumab if they want it as a first-line therapy? Surely, it should be about informed decision making and informed consent."

Full blog with comprehensive details on the therapy:

http://multiple-sclerosis-research.b...sed-in-us.html

[MSSpouse]

That's an interesting point--that waiting to use it until other things have failed can reduce the benefit. While we are on the side of being risk-averse in this MS household, I agree that MSers who have been fully informed on the risks and benefits should have the ultimate choice. Heck, which of the major proven therapies doesn't have huge side effects and risks? Perhaps after it's out in the field in the U.S. longer, the protocols for prescribing Lemtrada will change. Given the dynamics of the market in the U.S., insurers will probably get to make that call.