Danish diabetes specialist Novo Nordisk's shares fell by the largest amount in seven years in Copenhagen trading after a US Food and Drug Administration panel became deadlocked over Victoza (liraglutide), a once-daily human GLP-1 analog. Shares fell by as much as 13% on the day of the news, April 2.
The Endocrinologic and Metabolic Drugs Advisory Committee was tied six to six, with one abstention, after an increased risk of thyroid cancer was seen in animal studies of the diabetes candidate.
A majority of Advisory Committee members agreed that appropriate evidence of cardiovascular safety had been provided to rule out excess cardiovascular risk and risk of papillary thyroid cancer, but the panel was split on the question of whether the available data on C-cell tumors permitted approvability.
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