Fast-tracking of Tysabri questioned

THE fast-tracking of Tysabri to help the one-million sufferers of multiple sclerosis in the US needs to be questioned, said a leading stockbroker last night.

Bloxham Stockbrokers analyst Peter Jackson noted also that Merck’s painkiller Vioxx had to be withdrawn suddenly from the market last year. Those two events coming so close together “ask a lot of questions of the FDA and its recent drug approval methods,” said Mr Jackson.

Vioxx had not been fast-tracked, but it had to have FDA approval before going to market, he said.

Fast-tracking of a drug means it is allowed to go to the market after six months of initial trialling, which happened in Elan’s case, said Mr Jackson. The drug was licensed in November by the FDA and its withdrawal yesterday came as a total shock to MS sufferers.

Stock markets around the world also reacted with shock and the share price was decimated in both Dublin and New York.

For Irish drugs company Elan, Tysabri could have been a lifeline, with potential sales of the drug in the US alone estimated at $2 to $3 billion annually.

Of greater importance was the hope it offered multiple sclerosis sufferers, for which there is no cure.

Analysts now believe it will take weeks or months to re-establish the potential efficacy of the drug that both Elan and its partner Biogen saw as their passport to a solid future for both sets of shareholders.