Elan has taken a major step in its quest to return its MS drug Tysabri to the market by submitting reviewed patient data to the US drugs regulator.
Analysts said the submission by Elan and partner company Biogen was earlier than expected and is a positive sign for Tysabri's return to the market.
The FDA has 30 days to respond to the companies' initial request for a review application, but no decision on the re-licensing of Tysabri is expected before the end of October.
Eland and Biogen voluntarily suspended sales in February after a patient died from a rare brain infection following Tysabri treatment.
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Two other cases of the infection, one of them fatal, have been identified.