Tysabri info

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby Arron » Thu Aug 25, 2005 3:05 pm

Harry, thanks for sharing! It's interesting what he meant by "further info"-- perhaps it has something to do with the story on the front page regarding spontaneous remyelination being seen in mice exposed to Tysabri-like medications.
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Postby HarryZ » Thu Aug 25, 2005 5:30 pm

Arron,

Arron wrote:Harry, thanks for sharing! It's interesting what he meant by "further info"-- perhaps it has something to do with the story on the front page regarding spontaneous remyelination being seen in mice exposed to Tysabri-like medications.


I really wanted to ask him to clarify that statement but the conversation was taking place as we were leaving the examining room. Come to think of it, he did mention "similar type medications" as showing promise so perhaps that is exactly what he was referring. This neuro is a good doctor and very nice person as well. He treats the patient first and MS second.....something that not too many neuros do these days.

Harry
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Irish times article

Postby better2gether » Tue Sep 13, 2005 3:56 am

Irish times article

09/12/05

When a trial drug is withdrawn patients can pay a high price

Strict rules govern how firms test new treatments but withdrawing a drug can have adverse effects for patients trialing them, writes Dominic Coyle

Clinical trials are always a risk, both for patients and for the companies trying to prove the efficacy of their products.

From the company's perspective, trials can throw up all sorts of unexpected results despite the best research and preparation. Adverse results can be catastrophic for businesses whose shareholders and other financial backers invest largely on the basis of drug pipelines and the prospects of future sales success.

For the patient, the situation is even more critical. Most are seriously unwell in the first place, sick enough to take the risk of being dosed with an experimental drug that may prove beneficial but, then again, might not.

Ann (not her real name) has been battling with multiple sclerosis (MS) since her early 30s. As the condition progressed, she found her declining mobility made her more dependent on her husband and family. Worse still, for a woman who worked with her hands, she found herself suffering from diminishing sensation in her hands and feet.

When Elan Pharmaceuticals and Biogen Idec began clinical trials for Tysabri, then called Antegren, her neurologist put her name forward. Apart from the MS, Ann was young, healthy and had a clean medical history in that she had not been taking a series of medicines that might contaminate the trial.

"I enrolled in trials because I thought it mattered a lot, I thought, maybe, one person might not have to wake up every day, lying very still, taking mental inventory of fingers and toes before daring to move as a result of the decisions of myself and others to take part in the trial and that would have made it all worthwhile."

Ann was lucky initially. The experimental drug was designed to slow down the progression of her disease, not reverse its physical symptoms.

"I certainly did not expect to find a miracle, just a small step to help those walking behind me would have been enough. I'd have been happy with that. But it was a miracle, from my point of view, I was so alive. I was healthy and strong and so happy."

From a position where her mobility was borderline, Ann had almost fully recovered from the physical symptoms of her condition.

Ann spent three years on the trials and, as a result of her positive experience and that of the trial patients in general, Tysabri won fast-track approval from the US regulator, the Food and Drug Administration (FDA), for sale on the open market late last year.

Then, in February, disaster struck. Follow-up studies indicated that two people in a trial of the drug along with an existing Biogen MS treatment, Avonex, had contracted a rare and potentially fatal brain disease, progressive multifocal leukoencephalopathy (PML). One died.

The drug was withdrawn and one subsequent case of PML emerged in a trawl of existing patient data.

All three cases of PML involved people who had been taking a range of other drugs including immunosuppressants and steroids.

"I was gutted," says Ann, who was on the trial using Antegren/Tysabri on its own. No one on that MS trial has shown signs of PML. "Going into the trials, the most important thing for me was to never compromise them in any way, not even a sip of beer. That's why I am so disappointed that so many very sick people were in trials and that spelled a horrible verdict for a very good drug."

Six months down the line, Ann is now confined to a wheelchair and losing her sight. She is angry at losing the gains she had made and desperate to see Tysabri back on the market.

"I understand the importance of safety and the need for the companies and the regulator to be careful. But the fact is that the one thing that was allowing me to live with dignity has been taken away from me.

"I would sign any consent form to enable me to access Tysabri again. People need to understand how important trials are to those of us who find ourselves in this position," says Ann.

Elan and Biogen are currently talking to the FDA about bringing Tysabri back to market.



© The Irish Times

www.ireland.com/newspaper/health/2005/0 ... TRIAL.html
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Postby bromley » Tue Sep 13, 2005 4:54 am

Six months down the line, Ann is now confined to a wheelchair and losing her sight. She is angry at losing the gains she had made and desperate to see Tysabri back on the market.

"I would sign any consent form to enable me to access Tysabri again. People need to understand how important trials are to those of us who find ourselves in this position," says Ann.


This to me says it all, and I'd be surprised if there weren't a large number of people with this condition who share this woman's view. I once saw MS described as a disease of losses. It gradually eats away at all aspects of one's life - just look at poor Richard Pryor. To regain something of your old life (something as basic as walking / seeing etc) is worth any price (in my opinion, and that includes a risk of death). Alright, you could end up dying from PML, but MS always kills in the end after doing its utmost to destroy pretty much everything. As adults, we are surely entitled to make our own decisions and to have some dignity left. This is of course my opinion which may differ sharply from others. But for a while this treatment gave someone some happiness and some hope. And they shouldn't be denied the chance to have that - whatever the risks.

I'm always grateful for HarryZ's contributions, but there is bound to be a different interpretation of this issues from someone with the disease and someone without (as with HarryZ). Biogen are a commercial company and are interested in shareholder returns, the company may not have been completely transparent with the trial results (who knows!), but they produced a drug which some got great benefit from. As with all drugs there are risks and possibly very serious risks with this treatment. But if re-introduced the monitoring of patients is likely to be very high. For the sake of people like 'Ann' a reintroduction is a must (what's the alternative? (possibly abx))

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Postby HarryZ » Tue Sep 13, 2005 6:34 am

Bromley,

I totally agree with your perspective on how important it is for the patient to decide for himself/herself on whether to take a medication or not. In the case of MS, I have seen how the disease can "strip away" a person's life, layer by layer....I have first hand experience by watching how MS has done exactly this to my wife for 30 years. She chose not to take any of the drugs that became available in the mid 90's. Others made different choices.

But the article that Better posted had this sentence in it.

When a trial drug is withdrawn patients can pay a high price


And this is the main reason why I have been so vocal against Biogen/Elan and how they handled the introduction of Tysabri into the market.

From the article that I recently posted about monoclonal antibodies, the statements from some noted MS researchers, comments from MS docs that I know and information received from various people involved in MS medicine, a common theme was quite evident.....Tysabri had the potential of being a dangerous medication with MS patients and there was a lot of scientific information that simply wasn't known about it. Proceeding with caution and intense study was required before many of the "unknowns" were learned.

Now you would think that because of this, Biogen/Elan would take the cautionary road for this drug but as we saw, it simply didn't happen. Early positive results ended up with the entire plan for Tysabri being pushed ahead by at least one year. The fallout from this caused a huge amount of anguish and stress for MS patients. I am convinced that the incentive for this accelerated plan was $$$ motivated and certainly not in the best interests of the MS patient's health. But then again, this isn't surprising because we have seen how some pharmaceutical companies operate.

Now MS patients must do what they have often done....wait! And it could be quite some time before Tysabri returns if indeed the FDA allows this.

As a side note....today Marg and I are celebrating our 30th wedding anniversary :D

Take care.

Harry
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Postby bromley » Tue Sep 13, 2005 6:54 am

HarryZ,

HAPPY ANNIVERSARY.


Bromley

[maybe by the time you celebrate your 35th anniversary there will be some better / safer drugs on the market and ones which can benefit your wife]
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Postby Arron » Tue Sep 13, 2005 10:35 am

happy anniversary Harry!
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Postby dignan » Tue Sep 13, 2005 8:48 pm

I think I'm just squeaking under the wire at midnight Ontario time...happy anniversary!
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Postby HarryZ » Thu Sep 15, 2005 10:32 am

Dignan,

dignan wrote:I think I'm just squeaking under the wire at midnight Ontario time...happy anniversary!


When one has been married these many years, a few minutes either side of midnight won't make any difference :) Thanks a lot.

Harry
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Elan and Biogen Idec Provide an Update on TYSABRI(R)

Postby better2gether » Tue Sep 20, 2005 2:35 pm

20 September 2005

Elan and Biogen Idec Provide an Update on TYSABRI(R)

DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 20, 2005--Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that in the coming weeks they expect the safety evaluation of TYSABRI(R) (natalizumab) in Crohn's disease and rheumatoid arthritis will be completed, and that they will submit a supplemental Biologics License Application for TYSABRI in multiple sclerosis (MS) to the U.S. Food and Drug Administration.

On August 9, 2005, the companies announced the completion of the safety evaluation of TYSABRI in MS, which resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously reported three confirmed cases of PML, two of which were fatal.

On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of PML, a rare and potentially fatal, demyelinating disease of the central nervous system.

http://www.elan.com/News/full.asp?ID=758928
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Postby bromley » Wed Sep 21, 2005 8:07 am

HarryZ won't be a happy bunny when he wakes up and reads this!

Or perhaps he will (I've got a suspicion that he may have a stack of Biogen and Elan share under his bed!)
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Postby HarryZ » Wed Sep 21, 2005 8:16 pm

Bromley,

bromley wrote:HarryZ won't be a happy bunny when he wakes up and reads this!


Actually I read this last night as it has appeared on more than one MS forum.

Or perhaps he will (I've got a suspicion that he may have a stack of Biogen and Elan share under his bed!)


I may have my bad days, Bromley, but I don't think that I would ever go that low :)

Seriously, my feelings on whether Tysabri makes it back or not don't really count. What really is important here is the well being and safety of MS patients around the world. If further research and testing determines that this drug can be used safely with certain kinds of MS patients and it is beneficial in some way for them, then that is great. I and others have our doubts about that but it will be in the hands of the scientists and the FDA. As long as the process is done correctly!

So far, Biogen/Elan have cut as many corners as one can in introducing a new, potent drug to try and combat MS. They have done such a poor job so far that two class action suits against them have begun and thousands of MS patients are in limbo waiting for a final decision. I have read about some rumors on other sites that Tysabri is in for a very long, tough road of possible new approval. Time will tell just what may happen. But I think that most will agree that never have MS patients ever seen such a lousy, problem filled introduction of a new drug that was supposed to help them.

Take care.

Harry
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Postby DenverCO » Thu Sep 22, 2005 11:33 am

Can anybody tell me what a supplemental Biologics License Application means?
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Supplemental Biologics License Application

Postby better2gether » Thu Sep 22, 2005 1:07 pm

DenverCO

Biologic License Application (BLA)

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

Supplement

A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.

Supplement Number

A supplement number is associated with an existing FDA New Drug Application (NDA) number. Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001.


Supplement Type

Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). The supplement type refers to the kind of change that was approved by FDA. This includes changes in manufacturing, patient population, and formulation

http://www.fda.gov/cder/drugsatfda/glossary.htm#S
Last edited by better2gether on Thu Sep 22, 2005 1:16 pm, edited 1 time in total.
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Time to bring back a miracle drug

Postby better2gether » Thu Sep 22, 2005 1:12 pm

.
Time to bring back a miracle drug

By MICHAEL FUMENTO
Scripps Howard News Service
22-SEP-05

The makers of the multiple sclerosis drug Tysabri have just announced they will seek Food and Drug Administration approval to resume sales of the product. I don't have MS, but I couldn't be happier.

Since April, when I wrote about the biotech drug's sudden withdrawal two months earlier, I've been deluged with heart-rending e-mails from people begging me to do more to help bring it back. Despite readily qualifying as a "miracle drug," it got the yank (possibly under FDA pressure) because three users had developed an often-fatal neurological condition.

"Please see what you can do to persuade the FDA to do something for Tysabri's speedy return," pleaded one. "I don't think I can hold out much longer. Nothing else is stopping my attacks or the progression of my MS. Haven't I suffered long enough (29 years)?"

Said another, "For those who suffer from MS (the drug's withdrawal) is more then a travesty, it is the abduction of hope itself. My niece, age 25, has MS. She had hoped Tysabri would give her life back. That she might marry, have a family, and be happy. Her story is duplicated 400,000 times." That's about the number of Americans with MS.

Tysabri, jointly produced by Biogen Idec and Elan Pharmaceuticals, is incredibly effective against MS, a disease that attacks both the brain and spinal cord and can cause a host of symptoms including paralysis, blindness, fatigue, and sometimes death. There are other MS drugs, but none appear to be nearly as powerful or as well-tolerated as Tysabri. Results from two years of clinical trials showed a stunning 42 percent reduction in the risk of disability progression and an even more striking 67 percent reduction in clinical relapses.

In late clinical trials Tysabri has also apparently been extremely effective against Crohn's disease, a severe bowel disorder, and it was in human testing for rheumatoid arthritis. But these trials were also halted. Doctors told me their patients loved Tysabri, not just because it was so effective but because the side effects were so mild. So it came as a stunning blow to the approximately 8,000 using the drug, as well as a long list of persons waiting to get prescriptions, when the axe fell.

The neurological disorder linked to Tysabri, progressive multifocal leukoencephalopathy (PML), is caused by a common virus that the immune system usually keeps under lock and key. But in all three known cases among Tysabri users it was being tested in combination with another drug. Both are immunosupressants and apparently the combination allowed the virus to flourish. Nevertheless, there are NO known cases of PML in patients using only Tysabri, according to the FDA.

Tysabri's makers have now screened the entire database of more than 2,000 MS patients and are finishing a similar review of about 1,500 people from the Crohn's and arthritis trials. They've found no new PML cases.

It appears Tysabri would simply be on the huge list of both prescription and over-the-counter (OTC) drugs that have serious interactions with other drugs. The FDA also allows continued sale of countless drugs that when used alone kill thousands of Americans each year, such as aspirin and Tylenol. Why? Because the benefits are so huge. For that matter, there's been no withdrawal of an MS called Novantrone that causes such serious side effects as fatal congestive heart failure and leukemia.

Likewise, all the drugs that slow the development of rheumatoid arthritis carry FDA warning labels and some may cause death. Yet arthritis sufferers practically worship them.

There's a simple way of dealing with vital drugs that nonetheless may cause serious harm. It's called a warning label. In extreme cases it's made especially conspicuous by placing it inside a "black box." Tysabri's makers have already said that if the drug is reintroduced they want it to have a special warning, perhaps a black-box.

I use a black-boxed drug (implicated in liver failure deaths) and thank God it wasn't yanked as a "consumer protection" group had demanded. (It falsely claimed other drugs were just as effective and well-tolerated.) Otherwise I might be as desperate as those poor MS sufferers who were shown a glimpse of normal life only to have it brutally ripped away. They, too, deserve access to the best medicine available.


(Michael Fumento is author of "The Fat of the Land: The Obesity Epidemic and How Overweight Americans Can Help Themselves." He is also a senior fellow at the Hudson Institute. E-mail fumento(at)pobox.com.)

http://www.shns.com/shns/g_index2.cfm?a ... O-09-22-05
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