No new cases in Elan safety review

A SAFETY review of Elan's Tysabri drug to treat patients with Crohn's disease or rheumatoid arthritis has ended with no new cases of a potentially fatal brain disease, which led to the withdrawal of the drug from sale, being found.

The Athlone-based drug company has been testing patients who took Tysabri, taken off the market in February when it emerged that two people who were taking the drug to treat multiple sclerosis died from the brain disease PML. A third patient contracted the disease but survived.

Elan and Biogen Idec, which is co-developing Tysabri, said yesterday that more than 1,000 patients with Crohn's disease and rheumatoid arthritis participated in the safety evaluation. In total, 98% of the patients participating in the evaluation had a neurological exam by a consultant neurologist and an MRI scan. The review of patients who were using the drug for Crohn's disease and arthritis showed no signs of PML.

With the safety reviews completed and no new cases of PML, Tysabri is expected to get the approval from the US Food & Drug Administration (FDA) to be released back on the market.

Shares in Elan, which plunged heavily when Tysabri was withdrawn, gained as much as 10% yesterday. The shares have lost 60% of their value this year.

Brokers said the completion of the safety review is a positive for Tysabri getting back to the market.

Next week, the FDA will respond to Elan's request for a priority review of Tysabri for the treatment of MS and a decision could be made by the regulator within six months.

Ian Hunter, pharmaceutical analyst at Goodbody Stockbrokers, said: "The next significant step in the drug's return to market is the FDA's response to the request for a priority review of its licence application, which should be known within the next ten days. Acceptance would be a strong positive signal on the prospects for the drug's meaningful return to the market."

Before news of the patients' death emerged in February, Tysabri was seen as a cure for Elan's fortunes. Some analysts believed that the drug would have sales of more than €1 billion a year.