CAMBRIDGE, Mass., Jun 14, 2010 (BUSINESS WIRE) -- Genzyme Corporation /quotes/comstock/15*!genz/quotes/nls/genz (GENZ 49.50, +0.45, +0.92%) announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.
The FDA's Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Under Fast Track designation, alemtuzumab for MS is eligible for Priority Review and the FDA may consider for review portions of the marketing application before the submission of a New Drug Application (NDA) is completed.
"We are extremely pleased that our alemtuzumab development program has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program's review process," said Henri Termeer, Genzyme's chairman and chief executive officer. "Alemtuzumab is a potentially transformative therapy for the treatment of multiple sclerosis, and an important part of our future."
Alemtuzumab for the treatment of MS is currently being evaluated in two pivotal multi-center, multi-national trials, known as CARE-MS(SM) (Comparison of Alemtuzumab and Rebif(R) Efficacy in Multiple Sclerosis). The company's CARE-MS I Phase 3 trial is a randomized study comparing alemtuzumab to the approved therapy Rebif (high-dose interferon beta-1a) in early, relapsing-remitting multiple sclerosis (RRMS) patients who have received no prior therapy. The second Phase 3 trial, CARE-MS II, is comparing alemtuzumab to Rebif in RRMS patients who had active disease while on other MS therapies.
Both trials are fully enrolled and data are expected to be available in 2011.
About Campath(R) (alemtuzumab)
Campath(R) is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for the treatment of B-CLL in patients who have been treated with alkylating agents and for whom fludarabine combination therapy is not appropriate. The product was launched in its oncology indication in 2001 in the US, where it is marketed as Campath(R), and in Europe, where it is named MabCampath(R).
Campath for B-CLL has a boxed warning that includes information on cytopenias, infusion reactions, and infections. The most commonly reported adverse reactions in patients with B-CLL were infusion reactions (fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections.
I couldn't stand to see 0 replies on your post. Thanks for keeping the forum up to date! ccsvi alone won't be enough, I feel now that I've had both (campath and liberation) next I need (someone else's undifferentiated) stem cells.
And of course a diet for reduced inflammation and proper vitamin supplementation, sleep well and the right kind of exercise for "dead" limbs...
9 days status post stent & angio and too early to rant and rave, though i'm impressed so far. it was a local doc willing to give it a shot on a few of us. i'm a big proponent of calling every IR doc/ Vein specialists in your area & see if you can find one interested in trying it out. Can you do this in London? Call around and look for a doc to infuse campath "off label" for a small fee of $18,000 ?
or see a vein specialist willing to have a look @ "venous insufficiency" and not talk much about the other disease (MS)?
all the best to ya !
So far no serious tx related problems, but I know I am at a higher risk for thyroid since they screened for TPO antibodies, and i was positive, so I signed I knew I was at a higher rate for this. Also, I fear ITP! Haven't heard from fellow TIMS-Campath participant, Grumpster, who did get ITP post campath
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