FDA approves Actemra for GCA in the US

Eileen, the only thing I can find is this:

Media Release

Basel, 05 October 2016

FDA grants breakthrough therapy designation for Roche’s Actemra/RoActemra in giant cell arteritis, a form of vasculitis

 Roche recently announced positive results from a Phase III GCA clinical trial.  This is the Fourteenth Breakthrough Therapy designation for Roche medicines. There have been no therapies approved for GCA in more than 50 years

Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra/RoActemra® (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition.

then much more and then this paragraph:

Results showed that Actemra/RoActemra, initially combined with a six month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six or 12 month steroid-only regimen in people with GCA. Full data will be presented at an upcoming medical meeting in 2016.

That date (2016)  ties in with the last meeting of the Eular/Arc Committee.

As  I understand it  'Breakthrough Therapy Designation' does not mean full approval only extremely positive. I could be wrong.

It is not a replacement of pred , it is a steriod sparing agent. Progress yes, but not a replacement, and hopefully a very successful steroid sparing agent  - albeit extremely  expensive.

Wiki says:

"Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development. Section 902 of the July 9, 2012 Food and Drug Administration Safety and Innovation Act, allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.[1][2]

A breakthrough therapy designation can be assigned to a drug if "it as a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."[3]

Critics complain that most of these drugs are not actually “breakthroughs,” because they are based on preliminary evidence, including changes in surrogate markers such as laboratory measurements, that often don't reflect "meaningful clinical benefit." Even when they do, many of these benefits are not eventually confirmed in large clinical trials. And calling a drug a "breakthrough" drug gives the drug a marketing advantage which makes people believe that it is more effective than it actually is."

So yes, your comment is fair enough - but what Roche have done is get their step onto the ladder for the results of the large-scale clinical trial to be processed rapidly in terms of approval once they are published. Which should be soon one hopes.  

You must be very excited about the upcoming treatment.   👍🏼

Apprehensive, but excited too! My goal is to get off ALL the drugs of course.

Have had some 'interesting' experiences getting off Codeine in the past week.... lol

I probably should have Lodger! Paying the price now.

We can buy it over the counter here in Australia, but it's mixed with paracetomol, which is hard on the liver.... and given I have dodgy liver results already (from MTX) it certainly didn't need the extra stress.

I can get otc codeine with aspirin which I prefer to the version with tylenol as I understand aspirin and am wary of tylenol.  Use it only rarely for intractable migraine; it wipes me out and makes me feel unwell.  

It gives me a 'feeling of well being" .....lol

I think I now understand what drives drug addicts to seek out thier next hit!  

This will sound odd, but have you ever tried Feverfew tablets. 

My Mam and I only found out about way back when (over 40 years ago). 

Princess Margaret was alive then and she suffered from migraine and she took feverfew.  At that time there were no tablets - you just used the leaves but they had to be picked and used before the plant flowered. 

 Mam grew it on the windowsill and kept it going.   About 6 leaves were put in a small half slice sandwich  - it worked. 

When I had an hysterectomy (at 32)  one of the good things was  - the migraine disappeared. 

Sorry, we really need and edit button or a preview pane.

Yes, I used to take standardised feverfew.  I would take it for a few months, the headache frequency and severity would diminish, and I'd stop for a few months, until I noticed the headaches getting worse again.  I had a lot of headaches when I was sickening with PMR, and in fact described them to myself as a new kind of headache.  This is long before I knew anything about PMR and GCA.  When I was diagnosed my GP never mentioned GCA, but because I seemed to have some of the symptoms (the headaches, even a tight painful scalp) I proactively checked in with my ophthalmologist.  He turned out to be much more informative about prednisone than my GP had been, and told me that GCA was treated as a medical emergency.  But his very careful examination of my eyes revealed no sign of GCA, thankfully, and my taper has continued uneventfully, headache-wise.  I'd say my increasing age has helped reduce headache frequency to something negligible.  I still get the weather-related ones, and sometimes I think I react to a food.  May be sensitive to some of the mysterious additives and I guess I don't always avoid them when eating out.  

I think it's lovely that a common herb like feverfew can be so helpful.  I believe aspirin is derived from the salicylic acid in willow bark.  Most of our medicines can be traced back to something in nature, which is why it's puzzling the establishment seems so skeptical of their usefulness.

Was talking to an 81 year old pharmacist (ret'd) and we were just saying, what a lot of folk remedies, handed dwon from Mother to Daughter have disappeared over the past 50 years.   I still use quite a few and so does he.

Sadly I think we have entered a new Dark Age, we just don't know it yet.  

I'm pleased to report that here in German-speaking central Europe herbal and complementary medicine and traditional remedies are alive and kicking! They provide employment for a lot of people - because the tourists love them too!

Every few years there's a threat here to "regulate" traditional treatments, otc medicines and cosmetics in the same way as prescription drugs.  Needless to say, although many of us would like the chemicals in cosmetics to be evaluated for safety before being approved, and would also like guidance regarding safety and efficacy of "traditional" medicines, we are not happy with the thought that we may no longer be able to pop down to the local aromatherapy store, for example, to get our bottle of essential oil, or the health food store for our calcium supplements.  The proposal has just come into the news again.  Here we go again.