Elan's multiple sclerosis drug Tysabri should return to the U.S. market, an advisory panel from the Food and Drug Administration recommended today.
Tysabri sales were suspended in February 2005 after three patients developed a serious brain and spinal cord infection and two of them died.
The US Food and Drug Administration has been meeting for the past two days to decide if Tysabri should return to the market and will make a final decision at the end of the month.
Elan, and its business partner on Tysabri Biogen, have been trying to get approval from the US Food and Drug Administration for the treatment to be sold again, with controls to quickly spot serious side effects. The FDA's concern is whether PML can be treated even if it is caught early.
This was the second day of meetings, a large and vocal group of MS sufferers have been at the meetings arguing that it's a patients right to take the medication of their choice. They say Tysabri's efficacy far outweighs its side effects.
Tysabri had been hailed as a so-called blockbuster drug, which could halt the effects of certain debilitating forms of multiple sclerosis. Elan, along with its US partner Biogen had been running clinical trials involving 3,000 patients.
It received approval for the drug in November 2004 but voluntarily withdrew it at the end of February last year when it emerged that three patients had developed the rare brain disease PML. No further cases have been reported.
Elan suspended trading in its shares from 1pm Irish time yesterday for two days. Trading has also been suspended in the company's shares in London and New York.
