No New Cases in Tysabri Patient Screening
Posted on: Tuesday, 9 August 2005, 06:00 CDT
DUBLIN, Ireland - About 2,000 patients who took the suspended MS-fighting drug Tysabri have been screened for a deadly brain disease, but none showed signs of contracting it, the Irish and U.S. companies jointly developing the drug said Tuesday.
Elan Corp. PLC of Ireland and Biogen Idec Inc. of the United States said they were taking "preliminary steps" to resume clinical trials of Tysabri, which was withdrawn from the U.S. market on Feb. 28 amid fears its use could cause progressive multifocal leukoencephalopathy, or PML, a rare brain disease.
At the time, the companies said two multiple-sclerosis sufferers taking Tysabri had contracted PML, one fatally. They later confirmed a second fatal case of PML in a patient using Tysabri to treat Crohn's disease, a gastrointestinal disorder.
On the Irish Stock Exchange, Elan shares surged more than 25 percent to 7.50 euros ($9.15) within the first half-hour of trading.
Analysts said the announcement signaled growing confidence by both companies that Tysabri would eventually receive renewed, if restricted, approval from the U.S. Food and Drug Administration.
"The announcement is a clear signal to patients and the FDA of the companies' belief that Tysabri can make it back to the market," said Ian Hunter, an analyst for Goodbody Stockbrokers in Dublin.
The companies said they asked more than 2,000 MS sufferers who took Tysabri in clinical trials to be screened for signs of PML. They said 91 percent have complied so far, of whom 99 percent had a neurological exam and 98 percent had an MRI scan.
The screening produced "no new confirmed cases" of PML, the companies said.
"Given the high unmet medical need in MS and the therapeutic benefit we have seen with Tysabri, we are encouraged by these safety findings," said Whaijen Soo, senior vice president of medical research at Biogen Idec in Cambridge, Massachusetts.
"Patient safety remains our top priority," said Lars Ekman, executive vice president and president of research and development at Dublin-based Elan. "We are committed to finalizing the safety evaluation for Crohn's disease and rheumatoid arthritis, which is progressing well and on track to be completed by the end of the summer. We look forward to working with regulatory authorities to determine the path forward for Tysabri."
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On the Net:
http://www.elan.com
http://www.biogenidec.com
Source: Associated Press/AP Online
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