Shares in the pharmaceutical company Elan jumped 9.5 per cent to €21.2 on news that the group and its US partner Biogen Idec's multiple sclerosis drug had been designated for priority review by US regulators.
This morning the companies announced that the Biologics License Application (BLA) for Antegren (natalizumab) has been designated for priority review and accelerated approval by the US Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS).
The next step in the process is action by the FDA on formal acceptance of the application, which occurs within 60 days of submission.
The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need.
The companies anticipate action by the agency about six months from the submission date rather than 10 months for a standard review.
"The Priority Review designation underscores the significant unmet medical need in the area of MS," said Mr Lars Ekman, MD, executive vice president and president, Research and Development, Elan.
"We believe natalizumab will offer a new approach to treating MS and will bring hope to patients living with this disease."
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