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A prominent political donor for the Democratic party has apparently gotten his hands on an experimental drug to fight cancer over the objections of the drugmaker. The drug, Tysabri, which is manufactured by Biogen Idec Inc., is approved only for use in patients with multiple sclerosis or Crohn's disease. Biogen refused to give permission for it to be used in a single-patient investigation on the ailing donor, Fred Baron, in spite of pleas from many high-profile figures like former President Bill Clinton and cyclist Lance Armstrong. Nonetheless, Baron received the drug at the Mayo Clinic, which apparently managed to work...

Tysabri was pulled from the market in 2005 after three patients in clinical trials contracted a brain infection known as progressive multifocal leukoencephalopathy, and two patients died. Two patients were also taking Avonex. However, the FDA allowed the drug to return to the market in 2006 with a risk-management program. Crohn's disease is a chronic, progressive disease marked by inflammation of the bowel. The condition often causes abdominal pain and bleeding and can require surgery to remove diseased portions of the intestine. About 600,000 Americans have the disease. It wasn't immediately clear if there are any conditions attached to Tysabri's...

Final testing of MS drug launchedBiogen Idec said it has launched final, Phase 3 testing of an oral drug to treat multiple sclerosis. The Massachusetts company, which has a research campus in San Diego, said the drug will be tested in more than 2,000 patients in North America. The studies of BG-12, as the drug is known, are expected to last two years. The drug would be the third in Biogen Idec's portfolio of multiple sclerosis medicines. In June, the company reintroduced the drug Tysabri with partner Elan Pharmaceuticals based on a risk-management plan that stipulated it must be administered...

...The therapy in question is Tysabri, and for many MS patients it appears to halt progression of the degenerative neurological disorder. But a year ago... corporate partners Biogen and Elan "voluntarily" withdrew their drug because of FDA pressure and litigation fear after two patients developed a rare brain infection. That infection might have been linked to Tysabri, since the drug works by suppressing parts of the immune system. But these patients also had other immuno-suppressive therapies, and in any case the MS patients were almost all willing to run the risk.... But shortly before the deadline, the FDA announced it...

Many players on the field Hailed multiple sclerosis drug Tysabri is in FDA limbo, but researchers continue to attack the disease from all angles. By Mary Beckman Special to The Times March 27, 2006 STEPHANIE YELLIN-MEDNICK got through last year without the tingling in her hands that causes her to drop things or the weakness in her legs that knocks her off balance. Then the Food and Drug Administration pulled the drug that was helping her — Tysabri — off the market because of rare cases of brain infection in a few people taking it. "It was like a rug...

ASSOCIATED PRESS WASHINGTON -- A promising drug for multiple sclerosis should be returned to the market despite questions about a rare brain disease, scientific advisers told the government Wednesday - even as they continued to grapple with just who should be allowed to use it. The unanimous vote by advisers to the Food and Drug Administration came amid regulators' own concerns about the drug Tysabri, and whether there is any way to minimize risk from the apparent rare side effect. But the advisers were debating some controls on who could use the drug, agreeing to a manufacturer proposal for a...

The sponsors of Tysabri (natalizumab), Biogen Idec and Elan Corporation, announced today that the U.S. Food and Drug Administration has agreed to conduct a “Priority Review” of their application to return the drug back to the market. Tysabri was withdrawn in February 2005 due to safety concerns and is currently being re-evaluated by the FDA. (Read background information about Tysabri.) Agreeing to a Priority Review means that the FDA has approximately six months from the late September 2005 submission date to review the safety and efficacy data submitted by the companies, to seek advice from experts and comments from persons...

Drug withdrawal a travesty for MS sufferersMichael Fumento (archive) April 28, 2005 | Print | SendThe yanking from the market of both Vioxx and Bextra, members of a new generation of pain relievers called COX-2 inhibitors, has critics ripping raw flesh off the Food and Drug Administration. Inevitably, both the agency and pharmaceutical companies are under intense pressure to over-scrutinize new drugs. But over-caution can also cause tremendous, as multiple sclerosis sufferers using a recently-pulled drug called Tysabri can attest.Tysabri belongs to an incredibly promising new class of biotech drugs called monoclonal antibodies. Monoclonals have repeatedly shown an ability to...

The makers of the multiple sclerosis drug Tysabri said yesterday that a second patient who used the drug had been confirmed to be suffering from a rare but deadly brain infection. The confirmed diagnosis is likely to somewhat diminish the chances that the drug will be able to return to the market. The makers of the drug, Biogen Idec and Elan, halted sales and clinical trials on Monday, saying that one patient in a clinical trial had died from the brain infection and a second patient from the same trial, who was still alive, was also suspected of having it....

Tysabri Suspended From The MarketFebruary 28, 2005 Biogen Idec and Elan Corporation have just announced the voluntary suspension of Tysabri from the market and from all clinical trials due to safety concerns. Tysabri was approved for marketing in November 2004. According to the company press release, "This decision is based on very recent reports of two serious adverse events that have occurred in patients treated with TYSABRI in combination with AVONEX® (Interferon beta-1a) in clinical trials. These events involve one fatal, confirmed case and one suspected case of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of...

By THE ASSOCIATED PRESS BOSTON (AP) -- The makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.Stocks of both Biogen Idec Inc. and Elan Corp. tumbled, while shares of ther makers of rival MS drugs rose.The biotechnology companies said in a news release that they have suspended supplying and marketing the drug Tysabri and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.The companies...

New Treatment for Multiple Sclerosis February 23, 2005 Physicians and patients are excited about the newest treatment in the battle against Multiple Sclerosis. Multiple Sclerosis is a debilitating disease that attacks the central nervous system, which is the brain and the spinal cord. In December, the FDA approved a new drug to treat Multiple Sclerosis. The drug is called Tysabri. Patients are given Tysabri in an I.V. once a month. Dr. Vernon Rowe, Founder of the MidAmerica Neuroscience Institute in Lenexa, Kansas is calling the drug a revolutionary new therapy for MS Dr. Rowe says Tysabri will not reverse existing...

Nurse on cutting edge of treatment for MS Saturday, December 4, 2004 A 41-year-old Dumont man on Friday became one of the first in the nation to receive a recently approved drug that is expected to offer new hope to many multiple sclerosis patients. The medication, Tysabri, was approved by the federal Food and Drug Administration on Nov. 23, after just one year of clinical trials, because of its effectiveness in reducing the flare-ups of multiple sclerosis, while producing few side effects. "I'm looking at this as an early Christmas present,'' said Joe Giles, a nurse and director of critical...