Tysabri info

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

FDA Will Extend Regulatory Review Period

Postby better2gether » Wed Mar 22, 2006 2:03 am

22 March 2006

Biogen Idec and Elan Announce That FDA Will Extend Regulatory Review Period for the Reintroduction of TYSABRI® for Multiple Sclerosis

CAMBRIDGE, Mass. & DUBLIN, Ireland, Mar 22, 2006 (BUSINESS WIRE) -- Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that the U.S. Food and Drug Administration (FDA) informed the companies that the Agency will extend its regulatory review of TYSABRI(R) (natalizumab) as a treatment for multiple sclerosis by up to 90 days.

The companies have been informed by the FDA that the Agency requires additional time to review information regarding the TYSABRI risk management plan. Under this revised timeline, the companies anticipate action from FDA on or before June 28, 2006.

http://www.elan.com/news/full.asp?ID=834330
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Postby amelia » Wed Mar 22, 2006 8:25 am

Enough already with this dang dog and pony show!!! If it was a weight loss pill, even if it killed a few folks, well lets get it on the market now. If they were on the cusp of disability with no other treatments for them, it would ALL BE A DIFFERENT STORY!
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FDA Statement FOR IMMEDIATE RELEASE

Postby better2gether » Fri Mar 24, 2006 3:40 pm

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FDA Statement FOR IMMEDIATE RELEASE

March 24, 2006

Media Inquiries: Kathleen Quinn,301-827-6242
Consumer Inquiries: 888-INFO-FDA



FDA Statement On Tysabri Review Time

Biogen Idec and Elan announced on March 22, 2006, that the Food and Drug Administration (FDA) had extended the regulatory review period for the reintroduction of Tysabri (natalizumab) for multiple sclerosis (MS) by up to 90 days.

Under the Prescription Drug User Fee Act, extensions to the review period for an application can be triggered by a substantive submission from the sponsor. In this case, the information received was determined to be a major amendment to the pending application. The review period for the application was extended by up to 90 days to provide FDA time to review the new information.

This new submission is a revised Risk Management Plan (RMP), which takes into account the issues discussed, and recommendations offered, by the Peripheral and Central Nervous System Drugs Advisory Committee on March 7th and 8th of this year. Both the company and FDA believe that a RMP is important to help ensure safe use of the product.

This application continues to be a high priority. The agency is working intensively to complete review of this new information and will attempt to do so before the end of the 90 day extension period.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01340.html
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Re-Initiation of TYSABRI® Clinical Trial Dosing in MS

Postby better2gether » Wed Mar 29, 2006 2:33 pm

29 March 2006

Biogen Idec and Elan Announce Re-Initiation of TYSABRI® Clinical Trial Dosing in Multiple Sclerosis

CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--March 29, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that they have enrolled and dosed the first patients in the TYSABRI® (natalizumab) monotherapy safety extension study program in multiple sclerosis (MS).

Patients who previously participated in the Phase III MS trials and subsequent safety evaluation are eligible to be screened for entry in this open label multi-center study. Sites throughout Europe, the United States, Canada, Australia, New Zealand and Israel are expected to enroll patients. This safety extension study is being conducted under a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application in the U.S. and similar investigational approvals internationally.

Biogen Idec and Elan had previously voluntarily suspended TYSABRI from the U.S. market and dosing in all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.

On March 8, 2006, the Peripheral and Central Nervous System Drugs Advisory Committee of the FDA voted unanimously to recommend reintroduction of TYSABRI as a treatment for relapsing forms of MS. The companies anticipate action by the FDA regarding the reintroduction of TYSABRI in the U.S. on or before June 28, 2006. The companies' application for approval of TYSABRI as a treatment for MS is also under review with the European Medicines Agency.

http://www.elan.com/news/full.asp?ID=836716
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Re: Re-Initiation of TYSABRI® Clinical Trial Dosing in MS

Postby HarryZ » Wed Mar 29, 2006 6:08 pm

It would be interesting to learn what kind of patient monitoring has been set up for these new trials. Anybody heard anything as yet?

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Multiple sclerosis patients surveyed on drug Tysabri

Postby better2gether » Tue Apr 18, 2006 5:31 am

From IndyStar.com

April 18, 2006
News and notes

Multiple sclerosis patients surveyed on drug Tysabri

A survey of 200 patients in West Palm Beach, Fla., with a type of multiple sclerosis known as relapsing remitting has found that more than half would definitely or probably use a drug that significantly reduces frequency of relapse or progression in disability even if the drug involves a 1-in-1,000 chance of a fatal side effect.

The survey was conducted by John E. Calfee for the AEI-Brookings Joint Center for Regulatory Studies, established by the American Enterprise Institute and the Brookings Institution.

Those interviewed suffered substantial disability, most of them requiring a wheelchair or support for walking any significant distance, and over half suffering relapses in the past year. All were on drug therapy, while half had switched drugs and one-third had switched at least twice.

An FDA expert panel recommended unanimously last month bringing back Tysabri. The drug was pulled from the market in February.

http://www.indystar.com/apps/pbcs.dll/a ... -1/ZONES04
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Patient Power - The FDA Doesn't Have to Decide Everything

Postby better2gether » Mon May 01, 2006 7:33 am

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Patient Power - The FDA Doesn't Have to Decide Everything

By John E. Calfee
Posted: Monday, May 1, 2006

ARTICLES
The Weekly Standard (Washington)
Publication Date: May 8, 2006

Thousands of multiple sclerosis (MS) patients got an all-too-familiar message recently: Their lives are ruled by experts. The issue was their access to Tysabri, a breakthrough biotech drug with a unique ability to slow down the debilitating progression so feared by MS patients. The manufacturers pulled Tysabri from the market after two patients died from an unexpected side effect. Now the FDA has to decide whether to let the drug come back after new research has verified its potency against MS while also suggesting a 1 in 1,000 chance of the fatal side effect.

The FDA did what it usually does in these situations. It convened an advisory committee of experts. They got it half right. They unanimously recommended putting the drug back on the market. But they split on the crucial question of whether to recommend using the drug as a first-line therapy instead of waiting until patients fail on the current crop of drugs. And the committee strongly suggested that the FDA put together a potent "risk management" scheme to make sure Tysabri is used the way the FDA thinks it should be used.

Then the FDA's own experts took over. They are expected to reach a decision in the next month or so. No one thinks they will keep the drug off the market--but the FDA still has to decide which MS patients it will allow to use Tysabri and which patients it will keep from using Tysabri.

What about the patients, you ask? Well, a bunch of them testified at that advisory committee meeting, shuffling about with canes and wheelchairs, and almost all of them begged the FDA to bring Tysabri back. But as a cable news anchor said, the FDA decides on the basis of science, not emotion. Experts only, please.

In this instance, however, science doesn't have the answer. The issue, after all, is not whether the drug works or whether it sometimes kills people. It is whether the trade-off is worth it: Is a 1 in 1,000 chance of dying a risk worth running in order to reduce the much-feared "relapses" associated with MS by two-thirds or to diminish the formation of brain lesions by 83 percent? The experts on these questions are the patients. They are the only ones who can balance quality-of-life against the risk of death. Their views should be absolutely paramount.

Critics of patient power can correctly point out that people who testify at FDA hearings are not representative. MS sufferers who are happy enough without Tysabri, for example, are unlikely to travel to suburban Maryland to talk for three minutes before a panel of silent doctors and bureaucrats.

But, as it happens, we know quite a lot about what MS patients in general think of Tysabri. In addition to the usual clinical trial evidence on safety and efficacy, we have exceptionally sound survey data. In order to discover the preferences of MS patients, I worked with survey researchers at Roper Public Affairs to conduct a representative survey funded by Biogen Idec, one of the manufacturers of Tysabri. What we found is spectacular.

Roughly half of MS patients want to take their chances with Tysabri and its potentially fatal side effects. This feeling is consistent throughout the MS population regardless of level of disability. In other words, patients who are still early in the progression towards severe disability are about as interested in Tysabri as those who are already using canes and wheelchairs.

The patients also have strong feelings about FDA regulation. Seventy-one percent agreed with the statements, "If a drug has safety concerns, the FDA should warn people, but I should be free to decide with my doctor whether to use those drugs or not," and "I am capable of making my own treatment choices, based on the information and advice I get from my doctor." Patients want FDA expertise, but not FDA fiat putting valuable drugs out of reach.

This is not to say the patients want to decide everything all by themselves. Far from it. Three-fourths of our sample had seen their neurologist at least four times in the previous two years and usually talked about drug side effects. Eighty-one percent said they would be willing to visit their neurologist more often in order to get a better but riskier drug (only 2 percent disagreed; the rest agreed "somewhat").

There is some very good news here. The FDA has been under so much pressure in the past year and a half to crack down on risky drugs that you might think it would have a tough time with a drug like Tysabri. But if it pays enough attention to what patients want, its job looks a lot easier. The FDA should tread lightly in its risk-management plan for Tysabri. This is no time to second-guess patients and neurologists about when to start using the most effective method to slow down the otherwise relentless progression of MS. Nor is it a good idea to burden them with sweeping controls over exactly when the drug is used, although the plan to keep close tabs on PML, the fatal condition that triggered Tysabri's withdrawal, certainly makes sense.

Finally, this is not just about Tysabri and MS. When it comes to trading off the risks and benefits of most drugs, the best experts are the patients themselves, while medical experts are just well-informed amateurs. The FDA needs to know what patients want, and it should give those preferences very great weight indeed.

John E. Calfee is a resident scholar at AEI.


http://www.aei.org/publications/filter. ... detail.asp
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Postby amelia » Mon May 01, 2006 11:34 am

Soemthing that has always bothered me is:
If the manufacturers pulled the drug, NOT the FDA, then why does the FDA decide for the return of Tysabri?
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Postby HarryZ » Mon May 01, 2006 4:31 pm

Amelia,

amelia wrote:Soemthing that has always bothered me is:
If the manufacturers pulled the drug, NOT the FDA, then why does the FDA decide for the return of Tysabri?


You bring up a very good point and although I haven't made too many lengthy comments on Tysabri in recent weeks, I certainly will now!

Recently a friend of mine spoke with a contact who has worked in the FDA regulatory department of a large pharmaceutical company for 20 years. Their conversation lead to Tysabri and the pharma employee made the comment that no drug company would normally ever pull an already approved drug that possibly caused the death of 3 patients out of 3000 users. The question got around as to why Bigoen/Elan had done this and was there some other information that we didn't know about? Or was it simply the fact that Biogen/Elan had not done enough of their own research into Tysabri's potential problems and didn't want to chance possible further deaths?

One can understand the reasons why many MS patients would want to try Tysabri based on what Biogen/Elan has told us about the drug and the fact that anything available so far has very limited effect on MS. But I can't recall hearing that Tysabri's results have been peer reviewed so far and that everything that we know about this medication has been provided by Biogen/Elan.

A couple of weeks ago there was a mini conference in New York City in which the makers of the CRABs were invited to participate and discuss and compare their drugs for MS. Biogen did not send a rep and the other docs present (albeit reps for the other companies) supposedly said some very nasty things about Tysabri and Avonex. So you start to wonder just how good Tysabri may be and whether all the great comments that Biogen/Elan have made about it are totally true. I don't know but it is certainly discouraging to hear this kind of situation happening and you wonder if the MS patient has been given a false sense of hope which fuels their desire to try Tysabri regardless of the risk.

I believe the main reason that the FDA is so much involved in the decision making at this point is the fact that Biogen/Elan didn't know enough about the drug's potential problems and probably still don't. How can they when the only data they have is from the trials where 3 patients ended up with PML? Tysabri hasn't been used for any length of time by the masses and you can't really count the two months when the drug was available to anyone.

Biogen/Elan created a very high expectation for Tysabri and marketed the heck out of the drug....without truly knowing much about its dangerous side although they were given several warnings about this from people such as Dr. L. Steinman.

Now some press releases are trying to cast the FDA as the villains here and although I'm not a great fan of the FDA, I believe it was Biogen/Elan who have caused this mess from the very beginning. Now the FDA is carefully, scientifically and politically trying to fix it for the benefit of MS patients.....not an easy task under the circumstances.

Harry
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Postby amelia » Tue May 02, 2006 7:28 am

So you start to wonder just how good Tysabri may be and whether all the great comments that Biogen/Elan have made about it are totally true.

I really don't put much faith in what scientific data has to say about Tysabri. I enjoyed reading the people on this board and listening to others that took Tysabri and had a lessening of symptoms. How people improved after 1 or 2 doses. How they felt better. That speaks to me FAR better than any research data. You see, if something doesn't IMPROVE, not just "not get as worse" with Gary soon, his outlook on life will change dramatically. Probably to the point of not looking to live. Contrary to what DR's say, you can WISH yourself to death. Tysabri gave some improvement to most everyone that took it. It's about the improvement to us more than keeping him from getting worse. And you can't believe everything anybody tells you in this day and age. When Gary stopped his Copaxon, about 3 months after the fact, he had a dramatic sudden hair loss that lasted about 3 weeks. Now it has stopped. Coincindence? Maybe, maybe not. Nobody knows what is going on or will go on with any of the CRABs, regardless of the data. But it comes down to CHOICE! If Gary wants to risk death for life, it should be his choice, not a company, the FDA, etc.
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Postby HarryZ » Tue May 02, 2006 1:28 pm

Amelia,

I certainly hear what you are saying about improving as opposed to "not getting any worse". My wife Marg, who has had MS for 35 years now, has had some of the same feelings as Gary has. As I have said to many others, she is sick and tired of being sick and tired.

I'm not doubting what some people have felt after using Tysabri a couple of times, but one reader on another MS forum wondered if some of these users experienced a "better feeling" because of stopping one of the CRABs and going on a medication that didn't give you lousy side effects.
I guess we will have more information on this once Tysabri gets re-approved and many users start using it for the first time and for many months.

I agree with you in that the patient should have the final say as to whether to risk Tysabri but in this day and age of litigation, everyone has to cover their rear ends to protect themselves as much as possible against it. And that is one reason the FDA is very involved in crossing all the "t's" and dotting all the "i's" before they allow the drug back on the market.

Take care.

Harry
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Postby amelia » Tue May 02, 2006 1:38 pm

I think all the McDonald's type lawsuits for hot coffee has made everyone gun shy. In the long run, it hurts the general public. Probably so on some getting off the CRABs. Gary has felt better since leaving Copaxon. His biggest problem is spasticity and his Copaxon seemed to aggravate it.
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MS PATIENTS V. FDA OVERCAUTION

Postby better2gether » Thu May 18, 2006 4:08 pm

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Very interesting article.

MULTIPLE SCLEROSIS PATIENTS
V. FDA OVERCAUTION

by Lauren Roberts

http://www.wlf.org/upload/051906robertsLOL.pdf
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Re: MS PATIENTS V. FDA OVERCAUTION

Postby HarryZ » Thu May 18, 2006 5:36 pm

MULTIPLE SCLEROSIS PATIENTS
V. FDA OVERCAUTION

by Lauren Roberts


Lauren Roberts should be directing her anger and frustration against Biogen/Elan and not the FDA!

Had these pharmas followed their original plan of action and not become greedy by rushing everything in the first place, MS patients would likely now be able to choose whether they wanted to try Tysabri. But of course everything is on hold until the FDA and the "experts" try and sort out the mess.

Harry
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Postby amelia » Fri May 19, 2006 6:31 am

You know Harry, the past is the past. Let's move forward and those that wish to take it are just venting their frustrations. At the moment, the FDA is the hold up. :roll:
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