A European panel has started a review of the controversial Multiple Sclerosis drug Tysabri, sold by Biogen Idec Inc. (BIIB) and Elan Corp. PLC The European panel said its review will discuss "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment."
Christopher Raymond, an analyst with Robert Baird, said European regulators are unlikely to remove it from the market, but they may recommend that long-term patients take a break from using the drug to help balance risk. Duration of use is seen as raising the risk factor for PML.
Earlier this week, Biogen acknowledged that it is talks with the U.S. Food and Drug Administration to amend Tysabri's label to reflect increased PML risk with longer-term usage. Changing the label marks a shift for Biogen, which has long maintained there was no clear connection to duration and increased risk of PML, but mounting evidence has made that link clear.
(ELN), citing a much higher number of rare brain infections than previously disclosed.
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The European Medicines Agency, Europe's top pharmaceuticals watchdog, said on its website it has initiated a review to discuss any additional measures necessary to ensure the safe use of Tysabri.
'At worst, we anticipate (the agency) may recommend a drug holiday after an extended period on therapy,' said Christopher Raymond, an analyst at Robert W. Baird. 'But it is unlikely to suspend Tysabri's marketing authorization.'
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European regulators will review “any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment,” the European Medicines Agency said today in a statement on its Web site disclosing the new brain infections.
“These new cases are likely to alarm physicians whose comfort with the product had been increasing in recent months, and should catalyze academic and regulatory discussions about more active risk mitigation strategies,” said Geoff Porges, a New York analyst with Sanford C. Bernstein & Co., in a note to clients today.
Biogen finance chief Paul Clancy told Dow Jones earlier this week that the company will discuss how to communicate the link between long-term use of the drug and increasing incidence of the dangerous side effect.
Regulators might choose to recommend that patients who take the drug for long periods of time take breaks, or “drug holidays,” said analyst Christopher Raymond of Robert W. Baird & Co., in a note to clients this morning. Since so many patients depend on the product to control their symptoms, it’s unlikely that regulators would force it off the market, he said.
“We deem it highly unlikely that either FDA or EMEA would pull Tysabri from the market,” Raymond said. “With PML risk well known, we think the most likely scenario would be additional labeling restrictions suggesting perhaps a drug holiday after an extended treatment period.”