Novo stock took a plunge Monday morning, dropping 16 per cent on opening, but recovering slightly an hour later to hover around -12 per cent following the US Food and Drug Administration’s decision to hold off on approving two new insulin products.
“..the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed,” Novo Nordisk said in a stock exchange announcement, adding that it did not expect to be able to provide the requested data during 2013.
Tresiba and Ryzodeg have already been approved for use in the EU, Japan and Mexico.
Novo Nordisk CEO Lars Rebien Sørensen says he is convinced that the drugs Tresiba and Ryzodeg offer significant benefits for people who require insulin.
“We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review,” Rebien Sørensen says in the announcement.
The FDA’s decision is surprising, given that an FDA expert panel recommended last autumn that the two products should be approved.
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Edited by Julian Isherwood