TYSABRI® Multiple Sclerosis Clinical Trial Hold Lifted by FDA; Biogen Idec and Elan to Resume Clinical Trial Dosing in MS
CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Feb. 15, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced today that the Food and Drug Administration (FDA) informed the companies that they have removed the hold on clinical trial dosing of TYSABRI® (natalizumab) in multiple sclerosis (MS) in the U.S. The companies expect to begin an open label, multi-center safety extension study of TYSABRI monotherapy in the U.S. and internationally in the coming weeks. Patients who previously participated in the Phase III MS program are eligible for entry.
Biogen Idec and Elan had previously voluntarily suspended TYSABRI from the U.S. market and 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 September 26, 2005 the companies announced that they submitted a supplemental Biologics License Application to the FDA. Subsequently, the FDA designated TYSABRI for Priority Review. The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for TYSABRI in MS, the companies anticipate action by the Agency approximately six months from the submission date, or by late March 2006. The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review TYSABRI on March 7 and 8, 2006.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding the initiation of clinical studies of TYSABRI in MS. The initiation of clinical studies is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies current expectations include the risk that concerns may arise from additional data or analysis or that the companies may encounter other unexpected delays or hurdles. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise
CONTACT: Media Contacts:
Amy Brockelman, 617 914 6524
Davia B. Temin, 212 407 5740
Elizabeth Headon, 353-1-498-0300
Oscar Velastegui, 617 679 2812
Emer Reynolds, 353 1 709 4000
Chris Burns, 800 252 3526
SOURCE: Biogen Idec and Elan Corporation, plc.
I am not sure if that is going to work as a link or not!
I called my neurologist, and the nurse basically told me that the doctor hadn't heard anything yet, that she would be going to a conference in a month, and the nurse promised to let her know that I had called.
I didn't bother to remind her that she had not taken my name, since I don't believe it make a difference either way. Nurses are great gatekeepers.
I hope this all comes together soon!
Does the FDA really care? I think not. Viagra was killing old men right and left when it came out, BEFORE they realized you should not take it with heart problems. What is the benefit of Viagra? Life saving drug? NO! But was it pulled? Just a few days ago, Ritalin (not sure of spelling) has killed 24 and 19 of them being children. But did the FDA pull it? And if I was more up on medicines, I am sure there are many more! So, does the FDA really care about the "well being" of the patients? I really don't know how to answer that!"FDA remains very concerned about the potential for PML associated with natalizumab (Tysabri) use."b][/
I think the members of the FDA are giving us all way too many clues as to what they REALLY care about, and what their primary problems may be!
Can I be offhandedly rude and subtle at the same time, or what?
I am rushing off to classes, with my banjo on my knee, so to speak, and going through the rollercoaster of emotions so common to this condition. If only we could just zip down to Mexico and pick up a supply! Not happening. Sigh.
But, of course, getting a better appreciation of the risk will only come once patients start taking it again. It's a bit of a Catch 22 situation - taking the drug will come with risks but if no-one took the drug, the risks wouldn't be known.
And of course the other side of the equation is the potential benefits which will be valued differently by different individuals. Nothing is easy with this disease.
So for those of you who do start on this drug (in trials), we are grateful as you will be the ones that help define the risks to allow those of us in the future to make more informed decisions.
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Elan Reports Fourth Quarter and Full-Year 2005 Financial Results
Tysabri Expected Key Milestones 2006
-- Advisory Committee Panel Meeting, March 7, 2006
-- FDA action on Tysabri sBLA
-- Clinical re-dosing in the U.S. and International
-- European regulatory action regarding potential approval of
-- Potential re-marketing of Tysabri in the U.S. and Europe
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FDA Approved Controversial MS Drug Too Quickly: Expert
But others say Tysabri, now withdrawn from market, met standard data requirements
By Amanda Gardner
FRIDAY, Feb. 17 (HealthDay News) -- A multiple sclerosis drug pulled from the market early last year due to safety concerns was initially approved too quickly and probably should not go back on the market, at least not without more data, according to an expert writing in this week's British Medical Journal.
The article arrives a day after the U.S. Food and Drug Administration announced that the makers of Tysabri -- Biogen Idec Inc. and Elan Corp. PLC -- could resume clinical trials for MS patients who were previously treated with the drug under an investigational study.
An FDA advisory committee will also convene March 7 and 8 to consider the re-admission of the drug to market.
But the author of the BMJ article believes Tysabri -- whose generic name is natalizumab -- was approved too quickly in the first place.
"The rate at which Tysabri was first tracked is absolutely unacceptable for a condition like multiple sclerosis, which can last for 30 years," said the author, Dr. Abhijit Chaudhuri, a consultant neurologist for the Essex Centre for Neurological Sciences at Oldchurch Hospital, Romford, Essex, in England. "They did not even look into the side effects and this is unbelievable. It's a major failing."
Tysabri was pulled from the market on Feb. 28, 2005, after reports that three patients taking it had developed progressive multifocal leucoencephalopathy (PML), a progressive, neurodegenerative disease. The suspension took place just three months after the FDA granted accelerated approval of the drug for the treatment of relapsing forms of MS.
According to the National Institute of Neurological Disorders and Stroke, multiple sclerosis is an unpredictable disease of the central nervous system that can range from relatively benign to somewhat disabling to devastating. Most MS patients experience their first symptoms between the ages of 20 and 40, and most suffer muscle weakness in their extremities and difficulty with coordination and balance. These symptoms may be bad enough to hamper walking or even standing; in worst cases, MS can produce partial or complete paralysis.
Tysabri is a monoclonal antibody, engineered to attach itself to white blood cells called lymphocytes and prevent them from entering the brain, where they do damage that causes the disabling symptoms of MS. Tysabri had also been used to treat Crohn's disease.
Resumption of clinical trials using the drug doesn't pose a problem for Chaudhuri. "It's very simple," he said. "If a study is being conducted with ethical approval and physicians and participants are well aware of the risks, I have nothing to disagree about. Any scientific study where use of new product is closely monitored should go ahead."
But he is critical of the initial approval process for the drug. According to Chaudhuri, the FDA approved Tysabri only on the basis of short-term results from two unpublished trials, and before final data were available.
"Based on what we've seen so far, there is no evidence to suggest that this is very effective for MS," he said. "We're talking about a condition that affects young people fairly early in life and which lasts for 30 to 40 years, so it's a lifelong disease. Before you start using that, you must have convincing and compelling evidence that long-term disability is significantly reduced, at no cost for side effects. And I don't think we have that kind of information."
Chaudhuri's views aren't necessarily shared by other experts or by the companies involved, however.
"Tysabri has shown outstanding benefit in people with MS," said Davia Temin, a spokeswoman for Elan. "At the time of the suspension, Elan and Biogen put safety first and launched a rigorous medical scientific review of more than 3,000 patients treated with Tysabri. The results of this yielded no new confirmed cases of PML beyond the three previously reported."
Dr. William Sheremata, professor of neurology and director of the MS Center at the University of Miami School of Medicine, said, "MS is a disabling disorder and there really is a need to look for better treatments. The FDA's action was an attempt to try to keep the cost of drug development down, which has become a terrible problem. The agency was relying on over 30 years of experience with monoclonal antibodies."
But the resumption of the trial is still a far cry from restoring the drug to pharmacy shelves, and the outcome of next month's FDA advisory committee meeting remains unclear.
In a statement released Thursday, the FDA said that, "Although this treatment has been shown to have benefit in patients with relapsing-remitting MS, concern about the risk of PML associated with use of Tysabri remains."
The agency said it has worked with Biogen-IDEC over the past year to make sure that no other clinical trial participants have shown early evidence of PML, and to determine ways of minimizing the risk.
According to officials at Cambridge, Mass.-based Biogen IDEC, any return of Tysabri to the market would involve new labeling warning of potential risks to patients with weakened immune systems, who are most at risk for PML.
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