Novo Nordisk has been reported to the police by the Danish Financial Supervisory Authority for violating disclosure obligations concerning US rejection of its diabetes drugs Tresiba and Ryzodeq.
The FSA's complaint stems from the company's receipt of a complete response letter from the US Food and Drug Administration for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) on the evening of Friday February 8 this year. Novo said it published the news on Sunday February 10, "following an intensive investigation and evaluation of the implications and impact of the agency's decision".
The FSA, however, believes that Novo should have issued a company announcement on the Friday evening. The company believes it was entitled to delay public disclosure until the implications of the FDA's rejection "had been adequately analysed, which they had been on the Sunday".__Novo faced a similar investigation from the Nasdaq in Copenhagen but in May the company was informed by the stock exchange that it found no basis for concluding that there was any violation of the rules "and that it considered the matter closed".
Tresiba has already been approved in Europe and Japan, and had received a recommendation for approval from an FDA advisory committee in November last year. However, the company and investors were left stunned when the FDA then rejected the drug and demanded a new trial looking at the cardiovascular effects of the long-acting insulin.