FDA approves first drug to treat severe multiple sclerosis
10 replies, posted
[QUOTE]The Food and Drug Administration approved on Tuesday the first drug to treat a severe form of multiple sclerosis, offering hope to patients who previously had no other options to combat a relentless disease that leads to paralysis and cognitive decline.
The federal agency also cleared the drug to treat people with the more common, relapsing form of the disease.
The drug, which will be sold under the brand name Ocrevus by Genentech, showed the most notable results in patients with relapsing multiple sclerosis, appearing to halt progression of the disease with few serious side effects. In patients with the more severe form, primary progressive multiple sclerosis, the drug only modestly slowed patients’ decline, but medical experts described it as an important first step.
“This sort of opens the door for us,” said Dr. Fred D. Lublin, who was a crucial investigator for the clinical trial and is director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Hospital in New York. “Once we open that door, then we do better and better and better. It’s a very encouraging result.”
Genentech, which is owned by the Swiss pharmaceutical giant Roche, said Tuesday that it would charge a list price of $65,000 a year, which — though expensive — is 25 percent less than an existing drug, Rebif, that was shown to be clinically inferior to Ocrevus in the two clinical trials that led to Ocrevus’s approval.
Although people with the relapsing form of the disease have more than a dozen treatment options, many of the most effective drugs also come with significant side effects, which means that doctors often wait to prescribe them until a patient’s disease has advanced significantly. Ocrevus is viewed as relatively safe: Side effects included reactions at the injection site (the drug is infused every six months), and more upper respiratory infections and cold sores.
As a result, “it represents a new treatment option that has the potential to be used earlier,” said Dr. Peter Chin, the group medical director of neuroscience at Genentech, who was closely involved in developing the drug.
An estimated 400,000 people have multiple sclerosis in the United States, and about 15 percent have the primary progressive form of the disease.[/QUOTE]
[URL="https://www.nytimes.com/2017/03/28/health/fda-drug-approved-multiple-sclerosis-ocrevus.html?_r=0"]The New York Times[/URL]
This is actually brilliant news when compared to the existing treatments. Only issue is that it needs more long term safety research done though.
I have a friend who's 30 years old and has MS, which is incredibly tragic. This drug seems expensive but hopefully he'll have access to it.
[QUOTE=SleepyAl;52028125]I have a friend who's 30 years old and has MS, which is incredibly tragic. This drug seems expensive but hopefully he'll have access to it.[/QUOTE]
Here's to hoping the insurance companies won't write this off as being 'unprofitable' to provide to patients lol
Oh god, the timing of this.
[video=youtube;sCCDbOBNgGM]https://www.youtube.com/watch?v=sCCDbOBNgGM[/video]
Mikey Neumann is an awesome guy who, among other things, is a writer at Gearbox (he was pretty much responsible for Borderlands 1's writing -- not so much 2's) and runs his own movie review series on YouTube called Movies with Mikey. The above video was uploaded by surprise yesterday.
Mikey just got out of the hospital, weak and struggling, after ten days of being stuck in bed. I don't think he's released a definitive diagnosis, but he thinks it's MS. I saw video of him from a couple months ago, before all of this, and the transformation the attack/episode had on his body and capabilities was heart-breaking to watch. To think that he might be able to benefit from this drug and not suffer with MS for the rest of his life as it takes its toll on his body and mind is at least a bit of a relief.
It treats, but does it reverse its affects?
[QUOTE=Zero-Point;52029693]It treats, but does it reverse its affects?[/QUOTE]
Probably not since we don't even really know what causes MS.
[QUOTE=Zonesylvania;52028107]This is actually brilliant news when compared to the existing treatments. Only issue is that it needs more long term safety research done though.[/QUOTE]
Just curious if you've heard of a procedure called fecal transplant.
It's not commonly practiced, in fact many doctors seem to disagree with it's relevance.
My Aunt has had MS for many years, she wasn't doing very well a few months back and the doctors told her there were no more treatments available to her that wouldn't end up killing her.
One doctor she saw prescribed the fecal transplant procedure and since she had it done her symptoms of MS have been receding. Where as before she couldn't move her arms or upper body, now she can hold objects, prepare food, hold drinks, etc.
If possible, would you care to weigh in on this odd phenomenon?
[QUOTE=DiBBs27;52032558]Just curious if you've heard of a procedure called fecal transplant.
It's not commonly practiced, in fact many doctors seem to disagree with it's relevance.
My Aunt has had MS for many years, she wasn't doing very well a few months back and the doctors told her there were no more treatments available to her that wouldn't end up killing her.
One doctor she saw prescribed the fecal transplant procedure and since she had it done her symptoms of MS have been receding. Where as before she couldn't move her arms or upper body, now she can hold objects, prepare food, hold drinks, etc.
If possible, would you care to weigh in on this odd phenomenon?[/QUOTE]
That's purely anecdotal, there's now way of knowing if the improvement truely came from that procedure. If MS has something to do with gut fauna then theoretically it could make sense that fecal transplant could improve it, but MS is autoimmune so I don't see the connection off the top of my head.
[QUOTE=DiBBs27;52032558]Just curious if you've heard of a procedure called fecal transplant.
It's not commonly practiced, in fact many doctors seem to disagree with it's relevance.
My Aunt has had MS for many years, she wasn't doing very well a few months back and the doctors told her there were no more treatments available to her that wouldn't end up killing her.
One doctor she saw prescribed the fecal transplant procedure and since she had it done her symptoms of MS have been receding. Where as before she couldn't move her arms or upper body, now she can hold objects, prepare food, hold drinks, etc.
If possible, would you care to weigh in on this odd phenomenon?[/QUOTE]
Well the exact mechanism is poorly understood. Researchers speculate the curative effects might be because of a reduction in autoimmunity triggered by lowering the level of T-cells activated and released by the GALT, or lymphoid tissue of the gut, and the subsequent education of the systemic components of the immune system. This is the currently most acceptable theory for why this works in some cases.
[editline]30th March 2017[/editline]
[QUOTE=Mort Stroodle;52032709]That's purely anecdotal, there's now way of knowing if the improvement truely came from that procedure. If MS has something to do with gut fauna then theoretically it could make sense that fecal transplant could improve it, but MS is autoimmune so I don't see the connection off the top of my head.[/QUOTE]
[url]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4284325/[/url]
[QUOTE=Zonesylvania;52032715]Well the exact mechanism is poorly understood. Researchers speculate the curative effects might be because of a reduction in autoimmunity triggered by lowering the level of T-cells activated and released by the GALT, or lymphoid tissue of the gut, and the subsequent education of the systemic components of the immune system. This is the currently most acceptable theory for why this works in some cases.
[editline]30th March 2017[/editline]
[url]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4284325/[/url][/QUOTE]
Truly fascinating. Thanks for the insight on that.
In theory could a transplant potentially kick start the immune system? I imagine it might not be that simple though.
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