Sunday, September 16, 2012

IN BRIEF: FDA Just Approved Oral Relapsing Multiple Sclerosis Drug Aubagio

_**Teriflunomide (Aubagio, Genzyme/Sanofi) is coming into the MS market [1]. It is an oral drug, nice.**_

_**Efficacy: **_

"30% lower than the rate for those taking a placebo," said Russell Katz, MD,"   _**What does that mean?**_

Maybe not as clear as just a percent reduction in releases, think compounding. Sagepub has an article [2] discussing this topic. One thing is for sure you need all the intimate details of a study to know what was really measured. After several  years the number of relapses may have fallen by a much greater amount than 30% mentioned.  The efficacy of RRMS  Drugs (Relapsing Remitting Multiple Sclerosis) is measured in how well it decreases the_** annualized relapse rates (ARR)**_.

[![](http://www.medinewsdigest.com/wp-content/uploads/2012/09/Prescription_Drug-e1347668670241.jpg)](http://www.medinewsdigest.com/wp-content/uploads/2012/09/Prescription_Drug.jpg)

The new form of MS drugs: Oral

S**_uch rates are  subject to interpretation and statistical manipulation._**

Quoting [2] :

"…Out of the 72 randomized control trials, 56 (77.8%) articles had defined relapse or exacerbation, while 17 (23.7%) did not define the term relapse or exacerbation. Of these 56 articles, the study population consisted of 37 (66.1%) with RRMS, 8 (14.3%) were either RRMS or SPMS, and 11 (19.6%) involved other or unknown MS categories…"

_**The patient taking Aubagio has to accept the  following liver risks:**_

"…A boxed warning will alert prescribers to the risk for liver problems, including death, and a risk for birth defects with use of teriflunomide. "Physicians should do blood tests to check liver function before a patient starts taking Aubagio, and periodically during treatment," the FDA statement notes…"

Technically, this is how Aubagio works:

"…Teriflunomide is a once-daily oral immunomodulator developed as a disease-modifying therapy for MS. It reversibly inhibits …a key mitochondrial enzyme involved in  pyrimidine synthesis for DNA replication. _As a result, the drug reduces T- and B-cell proliferation and function in response to autoantigens but preserves the replication and function of cells _

_**Lexicon:**_

* Mitochondrion :  membrane-enclosed organelle, or mini organ, at the cellular level

_**Sources:**_

1. [Medscape](http://www.medscape.com/viewarticle/770822?src=nl_topic) ; "FDA Approves Second Oral Drug for MS" ; Sep 2012
2.  [sagepub ; Multiple Sclerosis ;](http://msj.sagepub.com/content/16/12/1414.full.pdf) ""Assessing changes in relapse rates in multiple sclerosis" ; 2010

URL: http://www.medinewsdigest.com/?p=5418

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