Genzyme’s MS Drug Aubagio Recommended By National Institute For Health And Care Excellence (NICE)

By Estel Grace Masangkay

Genzyme’s new multiple sclerosis drug Aubagio (teriflunomide) has received final guidance recommendation from the National Institute for Health and Care Excellence (NICE).

Aubagio (teriflunomide) is used to treat adult patients with active relapsing, remitting multiple sclerosis (RRMS). Teriflunomide is administered as a first oral, once-daily, and first line therapy for reduction of annualized relapse rates. It is also used to reduce disability risk accumulation compared to placebo during the Phase III controlled trials. The drug is developed as a selective immunomodulatory disease-modifying treatment for MS and has compounded anti-inflammatory properties.

Aubagio provides a viable alternative to injectable first-line RRMS treatment options. Carole Longson, NICE Health Technology Evaluation Center Director, said, “As an oral treatment with a different side-effect profile, teriflunomide offers a new option for treating relapsing-remitting multiple sclerosis, which could have a substantial impact on quality of life for people with relapsing-remitting multiple sclerosis.” Director Longson added that all current treatments for MS are injectables and can be associated with disagreeable side effects.

The EU granted marketing authorization for teriflunomide based on the TEMSO (Teriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) clinical trials. During the two-year, double-blind Phase III trial, teriflunomide 14 mg decreased the annualized relapse rate in patients with RRMS by 32% (TEMSO) and 36% (TOWER) compared to placebo. The drug also reduced sustained disability accumulation risks by 30% (TEMSO) and 32% (TOWER).

Benjamin Turner, Barts Health NHS Trust consultant neurologist, said, “Teriflunomide is a simple, effective, once-daily oral medication that will be invaluable for people with MS… This approval is great news for UK patients and especially those who cannot tolerate injections, as until now there have been limited treatment options open to them.”

With NICE’s final guidance recommendation, the National Health Service (NHS) is induced to a legal obligation to begin funding treatment for eligible patients within the next three months.

Source: http://manufacturing.pharmaceutical-business-review.com/news/nice-recommends-genzymes-multiple-sclerosis-drug-aubagio-in-final-guidance-230114-4164583

==============================================

==============================================

Thousands of
Multiple Sclerosis patients are getting worse each day, when currently used
medications are not working for them or their body refuses to accept the
medication.

Another Option is
needed and this Option Should be Lemtrada

The FDA on
December 30, 2013 Denies the use of Lemtrada for MS Patients. THIS was A sad
day for people with more active Multiple Sclerosis.

Lemtrada has been
approved worldwide, but not good enough for us it seems, in the USA.

We are more than
400,000 strong (living with MS) in the USA

WE NEED YOUR VOTE
to give another OPTION to those that Can benefit from this medication; hoping
to keep them from severe disability.

NEW CONTACT
INFORMATION —  (SEE BELOW)

YES, WE NEED YOUR
VOTE.

Also we need you
to write directly. WE NEED YOU TO send emails. –

We need this
request to go Viral —

• Let us FLOOD
the OFFICE of this FDA committee with emails, WITH the information shown above.

• Please copy and
paste what is typed and attach your name to that email and then send to: 

submit all Petitions to the new contact information
showing below:

Janet Woodcock, MD

Director, Center for Drug Evaluation and Research

Food and Drug Administration

10903 New Hampshire Ave

Silver Spring, MD 20993

[email protected] 

Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews