Complete response for Novo insulins

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) fell $26.89 (14%) to $165.40 on Monday after the company said it received a complete response letter from FDA for a pair of insulin products. According to Novo, the agency requested additional cardiovascular data from a dedicated CV outcomes trial prior to completing the review of the NDAs for Tresiba insulin degludec and Ryzodeg insulin degludec/insulin aspart to treat Type I and II diabetes in adults. Novo said it does not expect to be able to provide the requested data this year and on a conference call to discuss the letter said it would be "premature" to speculate on a time frame to provide the data. The company's stock move on Monday translates to a loss in market cap of $15 billion for a closing valuation of $92.6 billion.

Novo's Monday close is still above its close of $157.74 on Oct. 25, 2012, after FDA first disclosed concerns about the CV safety of the two products ahead of a meeting of the agency's Endocrinologic and Metabolic Drugs Advisory Committee. In November, the committee voted 8-4 that Novo had provided sufficient safety and efficacy data to support approval of Tresiba and Ryzodeg. The panel unanimously backed a CV outcomes trial of both drugs, but the eight members who supported the drugs said the trial should be done postapproval. At the meeting, Novo had presented a design for a five-year CV outcomes trial that would enroll 7,500 Type II diabetics (see BioCentury Extra, Nov. 8, 2012). ...