A panel for the regulatory agency considers whether to recommend the multiple sclerosis drug return to the market.
March 7, 2006

Analysts said Tuesday they expect a U.S. Food and Drug Administration advisory panel to recommend that Biogen and Elan’s multiple sclerosis drug Tysabri return to the market with strong restrictions on its use.

Developer Biogen and marketing partner Elan withdrew Tysabri from the market in February 2005 when three people taking the drug developed a fatal infection called progressive multifocal leucoencephalopathy (PML).

An FDA panel of experts is considering whether the FDA should allow Tysabri to return to pharmacy shelves and if so, for exactly whom it should be prescribed.

Approved in November 2004, Tysabri has been taken by about 7,000 people. Originally Biogen and Elan voluntary withdrew the drug when two MS patients taking a monthly dose over two years, in combination with another drug called Avonex, developed PML. But a third case, after the drug was taken off market, suggested the risks associated with it were even greater.

This third PML case occurred in a patient who had received only eight doses of Tysabri during an 18-month period for treatment of the bowel disorder Crohn’s disease (see Tysabri Inflicts Another Blow).

“The FDA was not shy about its views [early Tuesday morning] that were the drug to return to market, it expects that there will be additional cases of progressive myoclonic encephalopathy (PME) and that this would likely be associated with ‘substantial’ mortality,” wrote Stanford Washington Research Group analyst, Gregory K. Frykman.

Mr. Frykman added that he believed that the FDA’s comments about the potential for future problems with Tysabri were intentional so that critics “cannot claim that the FDA was not up front, forthcoming, and even blunt, about the potential downside of returning the drug to market.”

Limited Impact

If it returns to the market, Tysabri’s impact will likely be limited, in any case. By 2010, new, experimental drugs are likely to emerge and render Tysabri uncompetitive.

Industry organization PhRMA lists several companies with multiple sclerosis drugs in clinical trials. Among them, Immune Response Corporation, based in Carlsbad, California, is developing a product called NeuroVax, and Teva Pharmaceutical Industries is in late-stage trials with a compound called Copaxone.

“We expect the drug to return to the market with restrictions,” wrote Natexis Bleichroeder

analysts, Jon LeCroy and Stephen B. Shankman.

“The FDA seems to favor a last-resort indication (monotherapy, after failure using interferons and Copaxone), requiring mandatory registration of both patient and prescribing doctor,” they added.

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