A fourth illness may be tied to Biogen's MS drug
Finding could be blow to marketplace hopes
Biogen Idec Inc. has told the Food and Drug Administration that a fourth patient may have contracted a potentially deadly brain disease after being treated with the company's multiple sclerosis drug Tysabri.
If the case is confirmed, it would deal another blow to multiple sclerosis patients who have been hoping that Tysabri, which has been shown effective in reducing debilitating relapses, might again be made available. Cambridge-based Biogen Idec and its partner in Tysabri, Elan Corp. of Ireland, in February suspended sale of the drug and discontinued clinical trials after it was disclosed that one patient had died of a brain disease known as PML, and another was believed to have it. A third case of the disease was identified in March.
Confirmation of a new case could make it more difficult for the companies to convince the FDA that Tysabri is safe. Because PML is so rare, each additional confirmed case magnifies the drug's potential risks.
FDA spokeswoman Lenore Gelb said the agency is ''in communications with [Biogen Idec] on this case, as well as on the ongoing safety review."
The FDA approved Tysabri in November after reviewing only one year of data from planned two-year trials. It also shortened the approval process to six months from the date the companies submitted their application.
The first two cases of the disease, whose full name is progressive multifocal leukoencephalopathy, surfaced three months after the drug went on sale. PML is a rare brain disease in which a virus damages the central nervous system, often leading to disability and death within months.
The Globe obtained the report of the unconfirmed case under the Freedom of Information Act.
After being provided a copy of the report by the Globe, Dr. Patricia K. Coyle, an MS specialist and acting chairwoman of the Department of Neurology at the State University of New York at Stony Brook, said she thinks the FDA should investigate the new report ''quite vigorously."
The possible fourth PML patient is a 48-year-old woman who was taking Tysabri along with Avonex, another multiple sclerosis drug sold by Biogen Idec.
Dr. Douglas R. Jeffery, a neurologist at Wake Forest University School of Medicine in North Carolina, said the patient's symptoms would be ''quite rare" for multiple sclerosis, supporting the physician's diagnosis of PML. ''It sure sounds convincing to me," Jeffery said.
Jeffery said he is a paid consultant to Biogen Idec, Teva Pharmaceuticals, Serono Pharmaceuticals, Pfizer Inc. and Berlex Laboratories. He said he also receives research funding from the companies. ''I was extraordinarily saddened and disappointed when Tysabri was removed from the market," Jeffery said. ''I view Tysabri as a major advance in MS therapeutics."
A Biogen spokesman, Tim Hunt, declined to comment on the possible new case of PML. ''We're in the middle of our ongoing safety evaluation of Tysabri," he said. ''We hope to have our findings by the end of the summer. Beyond that we're not commenting on the particulars of our ongoing safety review." Biogen said it will discuss its findings with the FDA.
An Elan spokesman, Brian McGlynn, said the company would not comment ''on individual cases until the safety evaluation is completed."
Michael Peskoe, a former FDA attorney now with the Boston law firm Palmer & Dodge LLP, said that because Tysabri is already off the market, there is no obvious action the FDA could take. But the agency wants ''to find out everything they possibly can about Tysabri," he said
The possible new case is the third among multiple sclerosis patients who were taking both Tysabri and Avonex, according to the FDA report. Some doctors have speculated that the two drugs may together sufficiently weaken patients' immune systems to permit infections like PML. The three confirmed PML patients had weakened immune systems, sparking hope that Tysabri could return to the market if it was not used in conjunction with Avonex.
Last Thursday, Kelly Martin, Elan's chief executive, said he was optimistic about Tysabri's eventual return. ''It would be inconceivable to me that the drug wouldn't be available," he said at the company's annual meeting in Dublin.
Based on Martin's comments, shares of Elan and Biogen Idec have risen since Elan's annual meeting. Elan shares yesterday closed at $7.99, up 9 cents. They have surged 166 percent since dropping to $3 after the third patient with PML was revealed on March 30. Biogen shares yesterday gained 67 cents to close at $39.77, nearly its highest close since the third case was disclosed.
Biogen Idec is reviewing medical data from each of the roughly 3,000 patients who took Tysabri for extended periods in clinical trials. Patients are being reexamined by their neurologists. Some are undergoing MRI brain scans and having their spinal fluid tested for the virus that causes PML.
Jeffrey Krasner can be reached at email@example.com. Globe staff writer Diedtra Henderson contributed to this report. She can be reached at firstname.lastname@example.org