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

US FDA accepts MS drug Lemtrada resubmission for review

The US Food and Drug Administration (FDA) has accepted for review the Genzyme's resubmission of supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter...... Read More - http://www.ms-uk.org/lemtrada
Read more : US FDA accepts MS drug Lemtrada resubmission for review | Views : 2523 | Replies : 0


Alemtuzumab: Do the benefits outweigh the risks?

Alemtuzumab: Do the benefits outweigh the risks in treating multiple sclerosis? http://www.ms-uk.org/lemtrada
Read more : Alemtuzumab: Do the benefits outweigh the risks? | Views : 2077 | Replies : 0


NHS patients to get new MS drug

- Scientists have spent 25 years developing treatment at Cambridge
- Alemtuzumab infusion is given in two short courses over two years
- Despite costing £56,000, NICE has ruled treatment is cost-effective......Read More - http://www.ms-uk.org/lemtrada
Read more : NHS patients to get new MS drug | Views : 1817 | Replies : 0


Accelerated lymphocyte recovery after alemtuzumab........

Accelerated lymphocyte recovery after alemtuzumab does not predict multiple sclerosis activity

ABSTRACT

Objective: To test the hypothesis that accelerated peripheral blood mononuclear cell recovery after alemtuzumab treatment of multiple sclerosis is associated with recurrent disease activity and to investigate the claim that CD4 counts greater than 388.5 × 106 cells/mL at 12 months can be used to identify patients who may benefit from further treatment..... Read More - http://www.ms-uk.org/lemtrada
Read more : Accelerated lymphocyte recovery after alemtuzumab........ | Views : 2098 | Replies : 0


Lemtrada slows brain atrophy and reduces new MS lesions

- Consistent effects seen across key MRI measures of disease activity; Effects were sustained beyond two-year pivotal MS studies. <br><br>

- Approximately 80 percent of patients treated with Lemtrada did not receive a third course of treatment in the first year of the extension........ Read more - http://www.ms-uk.org/lemtrada
Read more : Lemtrada slows brain atrophy and reduces new MS lesions | Views : 1845 | Replies : 0


MS drug Lemtrada to be resubmitted to FDA for approval

Nearly four months after the Food and Drug Administration rejected a multiple sclerosis drug developed by Genzyme, citing the clinical trial’s design and a risk of serious side effects, the Cambridge biotech said Monday that it will resubmit an application for approval to the agency..... Read More - http://www.ms-uk.org/lemtrada
Read more : MS drug Lemtrada to be resubmitted to FDA for approval | Views : 2656 | Replies : 3


NICE says 'yes' to Genzyme's MS drug Lemtrada

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi subsidiary Genzyme's multiple sclerosis drug Lemtrada (alemtuzumab).

NICE is appraising alemtuzumab as a treatment for adults with relapsing & remitting multiple sclerosis, a chronic and disabling neurological condition that, as it progresses, can have a substantial negative impact on a person&rsquo;s quality of life........ Read More - http://www.ms-uk.org/lemtrada
Read more : NICE says 'yes' to Genzyme's MS drug Lemtrada | Views : 1796 | Replies : 0


Lemtrada(R) approved in Mexico for treatment of MS

Genzyme, a Sanofi company, announced today that Mexico's national regulatory authority, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations..... Read More - http://www.ms-uk.org/lemtrada
Read more : Lemtrada(R) approved in Mexico for treatment of MS | Views : 1938 | Replies : 0


MS drug Lemtrada investigators protest FDA decision

Several multiple sclerosis (MS) experts who were involved in the clinical development program for alemtuzumab (Lemtrada, Genzyme) have voiced their disappointment and frustration over the recent decision by the US Food and Drug Administration (FDA) not to approve the drug.

Stephen Krieger, MD, from Mount Sinai Medical Center, New York; Edward Fox, MD, from the Multiple Sclerosis Clinic of Central Texas, Round Rock; and Jeffrey Cohen, MD, from Cleveland Clinic, Ohio, all told Medscape Medical ...
Read more : MS drug Lemtrada investigators protest FDA decision | Views : 1980 | Replies : 1


Sanofi faces U.S. class action over MS drug Lemtrada

A U.S. law firm is launching a class action against France's Sanofi over what it calls misleading statements on the safety and efficacy of its multiple sclerosis drug Lemtrada.

Sanofi acquired Lemtrada when it bought U.S. biotech firm Genzyme for $20.1 billion in 2011. The drug's prospects took center-stage in a drawn-out takeover battle and led to a deal in which Genzyme shareholders received listed contingent value rights (CVRs) linked to Lemtrada's future success...... Read ...
Read more : Sanofi faces U.S. class action over MS drug Lemtrada | Views : 1977 | Replies : 0


 

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