FDA approves Aubagio

[Marco]

Federal regulators Wednesday night gave Genzyme Corp. the go-ahead to sell a new pill to treat multiple sclerosis in the United States. The positive ruling for the Cambridge biotechnology company’s therapy, called Aubagio, marks the Food and Drug Administration’s first approval of a Genzyme drug since French pharmaceutical giant Sanofi SA bought Genzyme for $20.1 billion in 2010.

Aubagio Summary
http://msworld.org/forum/showthread....09#post1369109

Prescribing Information (PDF format)
http://products.sanofi.us/aubagio/aubagio.pdf

News Article
http://online.wsj.com/article/SB1000...388247012.html

[kimik1]

Thanks for the information, Marco!

I was surprised by this; I pay close attention, but somehow this had slipped by me. I found out about it earlier this evening by a Facebook post from the NMSS!

What are your impressions? Does it look to you like they have a bit more trouble with elevated liver enzymes than some?

Sounded comparable to results from Rebif, from what I read, so maybe not astonishingly BETTER, but oral, which is a vast improvement over injection every day.

Thanks again for keeping us up to date.

Hope you're doing ok, been thinking about you.

Kim

[hotwing]

VERY EXCITING NEWS ANOTHER ORAL THERAPY

MARCO,

THANKS FOR POSTING, I THOUGHT ABOUT YOU WHEN I HEARD THIS NEWS AND AM GLAD TO SEE YOUR POST FOR EVERYONE.

I CLICKED ON THE "WSJ" ARTICLE AND UNLESS YOU TAKE THE JOURNAL YOU CAN SEE THE ARTICLE FROM THE LINK YOU POSTED. I THOUGHT I WOULD TELL YOU FYI. I TAKE THE JOURNAL SO I HAVE ACCESS TO THE ARTICLE. I AM NOT SURE IF YOU CAN COPY AND PAST THE "WSJ" ARTICLE ON THIS SITE OR NOT....

HOPE YOU ARE DOING WELL..

Federal regulators Wednesday night gave Genzyme Corp. the go-ahead to sell a new pill to treat multiple sclerosis in the United States.

The positive ruling for the Cambridge biotechnology company’s therapy, called Aubagio, marks the Food and Drug Administration’s first approval of a Genzyme drug since French pharmaceutical giant Sanofi SA bought Genzyme for $20.1 billion in 2010.

Aubagio Summary
http://msworld.org/forum/showthread....09#post1369109

Prescribing Information (PDF format)
http://msworld.org/forum/showthread....09#post1369109

News Article
http://online.wsj.com/article/SB1000...388247012.html

[Marco]

Kimbo,
This is just my OPINION on where this drug fits into our arsenal against MS. Aubagio arguably works better and is more tolerable than the "CRAB" drugs. I did say "arguably," but I am not trying to argue.

The market for this drug seemingly is:

- The enormous crowd that would prefer pills over injectibles (this immediately becomes a direct competitor to Gilenya).

- Patients with needle fatigue

- JCV+ and long-term Tysabri users

- New patients that are just beginning therapy


People that should probably avoid this drug:

- People that are satisfied with their current treatment plan. There is no reason to start a "new" medication if your existing one is working.

- Pregnant women or women that could become pregnant.

- Individuals with compromised livers. (note: I did read the elevated warning, but I also know the majority of our drugs put a definite strain on our liver).

- Individuals that are frequently ill

Patients should always consult their physician before starting or stopping any medication.

Closing thoughts:

Unfortunately, Aubagio did not fare better in trials to challenge the efficacy of Gilenya, but the side effect profile appears to be considerably better.

I still welcome any new drug to the market. It simply puts pressure on other companies to step up their game and hopefully reduce the cost of their own medications.

The elephant in the oral medication room remains BG-12. Aubagio may make a wave, but BG-12 might become a Tsunami. Only time will tell ...

I have my next appointment in early October and I will discuss going on Aubagio. My neuro wanted me on Tysabri, but I tested JCV+ so .... <insert quizzical look>

[Marco]

Hey Hotwing!!!

Thanks for the link info. Here is a link to the NMSS about Aubagio.

http://www.nationalmssociety.org/new....aspx?nid=6864

Sep 12, 2012

The U.S. Food and Drug Administration has approved teriflunomide once-daily pills (Aubagio,® Genzyme, a Sanofi company) to treat relapsing forms of MS. This is the second oral disease-modifying therapy approved for the treatment of multiple sclerosis. The therapy is expected to be available for prescription by October 1, 2012 in the U.S. The company has also applied for regulatory approval in other parts of the world.

[*]Note the slight delay from approval to availability.

[kimik1]

Marco,

Thanks for your thoughts on Aubagio and it's potential. I agree with you based on the reported efficacy of Aubagio being similar to Rebif that it may well be a great first line drug for those who do not want injections, etc. I also agree that from efficacy data being reported on BG12, a tsunami is possible and likely with its release.

With regard to JC virus status, for you, I'm not sure to be happy or sad. It supports your position that you didn't want to be on it, so in that regard, I'm happy for you. However, it's a deterent to putting you on it, so in that way, Im sorry. So far, my experience has been good.

I'm currently considering plasma exchange for treating this now 10 week relapse and have a conversation going with my neurologist and two PAs who run an MS clinic in Kansas City. Hoping for some continuation of this converation today. Also considering the possibility (which would have much less short term impact on my life) of 10 days of Acthar Gel, though the 5 day treatment failed.

ANyway, hope you're working on recovery. Been thinking about you tons, sending positive energy and thoughts your way, friend. THanks, as always, for the great med update!

Kim

[MarkLavelle]

People that should probably avoid this drug:

- People that are satisfied with their current treatment plan. There is no reason to start a "new" medication if your existing one is working.

- Pregnant women or women that could become pregnant.

- Individuals with compromised livers. (note: I did read the elevated warning, but I also know the majority of our drugs put a definite strain on our liver).

- Individuals that are frequently ill

Since Aubagio apparently works by suppressing the immune system, I would add:

- Individuals with previously compromised immune systems (e.g.: chemotherapy, radiation).

That's why I'm on Copaxone...

[mike1963]

Taking Aubagio...

I took gilenya for almost a year. Exacerbation occurred. Stopped gilenya. Then did another solumedrol 5 day stint. Then started Aubagio & been taking for 2 months now. Time will tell.....

[JerryD]

Since the new drug is Aubagio, it would be great to hear as much as possible from those of you that are taking it. If you are ' free' from relapses from this point, that would be good to hear. Also, if there are problems with side effects, that would be worth reporting to us. All first hand info is worth reporting and would be appreciated. Good luck

[mike1963]

JerryD & all, only been taking Aubagio for 2 months now & no exacerbations so far. (The last dose of solumedrol may be assisting with this also remember) Haven't had any side effects either. Time, with any of these meds we take, is the experiment for success to see if the med does what it's supposed to do.

[JoyNBolt]

FDA approves Aubagio

It could have been done earlier!!!!
______________________________

[moolk]

I took gilenya for almost a year. Exacerbation occurred. Stopped gilenya. Then did another solumedrol 5 day stint. Then started Aubagio & been taking for 2 months now. Time will tell.....

Please keep us informed!! Wishing you the best