Tysabri in Europe

bromley · Family Elder Joined: Sep 11, 2004 Posts: 1840

EU to Rule on MS Drug Approval 16 March 2006

Biogen Idec Inc. executive said the company and partner Elan Corp. may get a decision by midyear on European approval of their Tysabri multiple sclerosis drug, which had been pulled from the U.S. for safety reasons.
A European Union advisory panel may release its decision by as early as next month, with a final ruling coming a couple months later, Hans Peter Hasler, a senior vice president of Biogen, said in an interview in Zurich. The medicine hasn't been on the market in Europe.

Earlier last week, a Food and Drug Administration panel voted to urge that the agency let Tysabri back on the U.S. market a year after it was withdrawn because of links to a rare brain infection. Biogen Chief Executive Officer James Mullen said he plans to introduce Tysabri in the U.S. by June.

"The recommendation to the FDA could accelerate the process in Europe," said Hasler, who oversees Biogen's international operations. "If everything goes well, we could get a final decision by the EC this summer."

To persuade the U.S. panel, patients and the companies cited research showing Tysabri is twice as effective as other drugs against a neurological disease that affects 400,000 Americans. Investors had anticipated Tysabri would be limited to people not helped by other drugs. The less restrictive approval may allow annual sales to reach $500 million to $1 billion in four years, said Eric Schmidt, an analyst at Cowen & Co.

The timing of Tysabri's introduction will depend on how quickly the company and regulators can complete a program to manage the risk of progressive multifocal leukoencephalopathy, or PML, the rare, fatal brain infection linked to Tysabri, Mullen said. The FDA is supposed to make a decision by March 29.

Tysabri's prescribing information will include the FDA's strictest warning that the drug is associated with death and disability caused by PML, Biogen said. Doctors will be instructed to immediately suspend treatment if patients show signs of the disease, and they should begin testing for PML and the virus that causes it.

Tysabri sales were halted on Feb. 28, 2005, on the first reported death from PML, wiping out $17.8 billion in combined market value for Biogen and Elan. More extensive reviews revealed that two patients died and a third developed PML and survived.

Tysabri had been seen as the best hope in a decade for the world's 2.5 million MS patients, with potential annual sales of $3 billion. MS is a neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis.

Source: Deseret News (Salt Lake City)