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A board to discuss the soon-to-be released drug Campath as a treatment for Multiple Sclerosis

FDA refuse to file letter

The FDA have sent Genzyme/Sanofi a refuse to file letter. They're not asking for more trials, just for more info at the moment, but it will put back approval in the US by another 6 months or so. The EMA in Europe have accepted the application.
Read more : FDA refuse to file letter | Views : 1545 | Replies : 0


pseudo relapses after Campath

I had one high dose of Campath 2-3 years ago. I got ITP and could not have another dose. I have not had any major relapses since the treatment. However, I have had and am currently experiencing pseudo relapses where I have worsening symptoms and periods of increased disability, which come and go frequently. I am not sure if I should even report these to my neuro. It is hard to tell. HAs anyone experienced ...
Read more : pseudo relapses after Campath | Views : 2965 | Replies : 8


Withawal of campath

Apparently in the US and most of Europe, Sanofi are withdrawing the unlicensed use of Campath for MS treatment ie use outside of a recognised trial. Drs. will only be able to get it for named cancer patients. I think this starts in the US in November. This is in preparation for it to be licensed under Lemtrada once the EMA and FDA have looked at it.
Read more : Withawal of campath | Views : 1601 | Replies : 0


Shingles - lucky me -NOT

I had a third dose of alamtuzumab a couple months ago. I took the acyclovir as instructed and all was good but I took my triplets for a well visit and they got the chicken pox booster. I didn't think about it because I've had chicken pox. I forgot about the possibility of getting shingles and now I have them. Please keep it in mind when you get you doses.
Read more : Shingles - lucky me -NOT | Views : 1359 | Replies : 0


Approval sought for Lemtrada(TM) (alemtuzumab) for MS

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Genzyme, a Sanofi company , today announced that the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of Lemtrada(TM) (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS). Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare.

Genzyme's clinical development program for Lemtrada included two Phase III studies in which ...
Read more : Approval sought for Lemtrada(TM) (alemtuzumab) for MS | Views : 1726 | Replies : 0


Lemtrada (alemtuzumab) improved disability scores in MS pts

Lemtrada (alemtuzumab) improved disability scores in MS patients over Rebif

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Genzyme, a Sanofi company , reports today additional data from the Phase III CARE-MS II trial. Accumulation of disability was significantly slowed in patients with multiple sclerosis (MS) who were treated with alemtuzumab versus Rebif(R) (high dose subcutaneous interferon beta-1a), as measured by the Expanded Disability Status Scale (EDSS), a standard assessment of physical disability progression.

In addition, significant improvement in disability scores was ...
Read more : Lemtrada (alemtuzumab) improved disability scores in MS pts | Views : 2072 | Replies : 0


Alemtuzumab more effective than interferon β-1a at 5-years

Alemtuzumab more effective than interferon β-1a at 5-year follow-up

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Summary: The authors present 5-year follow-up data from the CAMMS223 study, reporting on the long-term safety and efficacy of alemtuzumab treatment compared with interferon β-1a in early, active relapsing-remitting multiple sclerosis (RRMS). Over 5 years, alemtuzumab lowered the risk of sustained accumulation of disability by 72%. The annualised relapse rate over the 5 years was 0.11 for alemtuzumab and 0.35 for IFNβ-1a.

Most commonly occurring ...
Read more : Alemtuzumab more effective than interferon β-1a at 5-years | Views : 1934 | Replies : 0


Successful phase III results for Alemtuzumab (Lemtrada(TM*))

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Genzyme, a Sanofi company , reports today that the Phase lll CARE-MS ll trial met both of its co-primary endpoints.

Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab (Lemtrada(TM)) as compared with Rebif(R) (44 mcg subcutaneous interferon beta-1a).

Results for both of these co-primary endpoints were highly statistically significant. CARE-MS II is the randomized Phase III clinical trial comparing the investigational drug alemtuzumab to ...
Read more : Successful phase III results for Alemtuzumab (Lemtrada(TM*)) | Views : 3834 | Replies : 14


Alemtuzumab offers hope for Multiple Sclerosis treatment

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The first drug to show signs of not just halting multiple sclerosis (MS), but actually reversing the nerve damage caused by the condition, has taken a significant step towards clinical approval.

The results of a phase III trial, presented on 22 October at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis, in Amsterdam, found that 78% of patients treated with the monoclonal antibody alemtuzumab ...
Read more : Alemtuzumab offers hope for Multiple Sclerosis treatment | Views : 1993 | Replies : 1


Lemtrada (Campath) appears to help MS patients in study

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New data from a late-stage trial showed that 78 percent of patients treated with Lemtrada remained relapse-free for two years, compared with 59 percent using Rebif, an older multiple sclerosis drug sold by Germany's Merck.

Lemtrada is a key experimental product at Sanofi's Genzyme unit. The fortunes of the drug are closely watched by holders of Genzyme Contingent Value Rights certificates issued to shareholders as part of the U.S. company's takeover deal.

CVRs represent ...
Read more : Lemtrada (Campath) appears to help MS patients in study | Views : 1681 | Replies : 0


 

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