FDA Delays Novo Nordisk’s Tresiba and Asks for Additional Cardiovascular Data

On February 8, Novo Nordisk received an FDA complete response letter (CRL) for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/aspart). Tresiba is Novo Nordisk’s new ultra-long-acting basal insulin, and Ryzodeg is a fixed combination of degludec and the ultra-rapid-acting insulin Novolog. In the CRL, the FDA asked for additional heart disease data from a cardiovascular outcomes trial (CVOT) – such trials, depending on the company’s discussion with the FDA, can take multiple years, require thousands of patients, and cost hundreds of millions of dollars. The CRL came as a surprise, as an FDA advisory committee voted 8-4 in favor of Tresiba’s approval last fall. Furthermore, European and Japanese regulatory authorities have already approved Tresiba. Currently, Novo Nordisk is waiting to communicate with the FDA on the CRL and presumably on trial requirements.

As for other updates on Novo Nordisk, the company recently advanced a new long-acting insulin (LAI287; NN14336) into phase 1 trials – notably, it has the potential for once-weekly dosing (!), which could make it much less burdensome to take if it is able to maintain glucose levels and not cause excessive hypoglycemia or weight gain. Novo Nordisk is also working on developing Victoza (liraglutide) as an addition to insulin therapy for type 1 diabetes. An early study demonstrated that Victoza decreased daily insulin requirements as well as body weight. The company also plans to begin a large phase 3 study in the second half of this year. In addition, Novo Nordisk continues to investigate Victoza as an obesity medication; all phase 3 study trials are scheduled to be complete in June 2013. –MA