Saturday May 27th 2017

[Editorial] Alemtuzumab and the value of neurological research

The announcement by the US Food and Drug Administration (FDA) on Dec 27, 2013, to reject an application for the use of alemtuzumab in relapsing-remitting multiple sclerosis (MS) has caused a stir within the neurological community. Investigators involved in two large phase 3 trials that tested its safety and efficacy expressed discontent; patients’ organisations protested the decision; the drug makers announced their intention to appeal this initial ruling (which is subject to further regulatory review); and even an opinion piece in the Wall Street Journal called for FDA reform, given such “vivid example of the serious problems besetting US drug regulation”. (Source: Lancet Neurology)

MedWorm Sponsor Message: Find the best Christmas Sales, Boxing Day Sales and January Sales here.

Excerpt from:

[Editorial] Alemtuzumab and the value of neurological research

Leave a Comment

More from category

Revisions Underway to McDonald Criteria on MS Diagnosis Revisions Underway to McDonald Criteria on MS Diagnosis
Revisions Underway to McDonald Criteria on MS Diagnosis Revisions Underway to McDonald Criteria on MS Diagnosis

An expert panel is tackling the first revision to the multiple sclerosis diagnostic criteria in 7 years. Among proposed [Read More]

Connecticut State Budget Call to Action
Connecticut State Budget Call to Action

/About-the-Society/News/Connecticut-State-Budget-Call-to-Action [Read More]

A Surge of New Drug Data in Multiple Sclerosis A Surge of New Drug Data in Multiple Sclerosis
A Surge of New Drug Data in Multiple Sclerosis A Surge of New Drug Data in Multiple Sclerosis

Medscape sits down with two neurologists to discuss advances in multiple sclerosis as presented at this year's American [Read More]

Progress on Bills to Address Step Therapy
Progress on Bills to Address Step Therapy

/About-the-Society/News/Progress-on-Bills-to-Address-Step-Therapy [Read More]

Brain Gadolinium Deposition Varies With Contrast Agent in MS Brain Gadolinium Deposition Varies With Contrast Agent in MS
Brain Gadolinium Deposition Varies With Contrast Agent in MS Brain Gadolinium Deposition Varies With Contrast Agent in MS

Gadolinium accumulation in the brain is greater with linear GBCAs than with macrocyclics. Multiple sclerosis experts [Read More]