Lemtrada is given once a year as an infusion. Patients get five doses over five days. More than 70 percent of patients with early disease given the drug in a study had no relapses or progression of disability for four years, compared with 35 percent of those given Merck KGaA’s Rebif.
Side effects included infections in 72 percent of patients, thyroid complications and cancers. Most infections were in the respiratory or urinary tracts and cleared with treatment.
“To say Campath is going to be a game changer and solve all the problems, I don’t know if that’s true,” said Howard Weiner, director of the Partners Multiple Sclerosis Center at Brigham & Women’s Hospital in Boston. “It’s a theoretical cure, but to know that you need to follow people for 10 years. It’s a very strong drug and has potential side effects.”
Lemtrada is in the third and final stage of tests generally needed for U.S. approval. Results from one of those tests, in patients without prior MS treatment, are expected mid-year, Genzyme said today in a statement. A second study of previously treated patients will be done by the end of 2011. Genzyme said it expects U.S. approval in the second half of next year.
Safety Data Genzyme has been transparent with its safety data, John Lacey, a spokesman for the Cambridge, Massachusetts-based company, said in an e-mail.
“The analyses to date have consistently indicated unprecedented efficacy versus active treatment and adverse events that were detectable by standard blood tests and easily managed with standard treatments,” Lacey said. “Our Phase 3 program is continuing to progress well with the safety committee as recently as December indicating that no new concerns had been identified and that the trials should continue.”
GENZ - I read the PR quickly since I have no skin in the game.
But if I got it right you only get $1 for approval of Lamtrada. The balance of L-CCVR payments are for sales targets.
Campath has so dramatic an impact on the immune system that it carries significant risks. No way I would want it until it had at least 5 years of market use.
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