Sticking Point: FDA Rejects Novo Nordisk Insulin

In a huge setback to Novo Nordisk, the FDA has rejected its new Tresiba insulin and wants a cardiovascular outcomes trial before a new review can be completed, a move that is widely expected to delay approval for at least two years. The rejection comes less than a month after European regulators approved Tresiba, which Novo has been counting on to bolster its standing in the hyper-competitive diabetes market. “It’s not a good day for diabetes patients in the US, it’s not a good day for Novo Nordisk and for Novo Nordisk shareholders,” Novo ceo Lars Soerensen said on a conference call with analysts earlier today. “We will do our utmost to ensure this is solved as expediently as possible… We were both very surprised and very disappointed.” In a statement, he noted approval also hinges on correcting problems in a manufacturing plant (see FDA letter here). Indeed, only two week ago, Soerensen told analysts that Novo (NVO) was making progress in talks with the FDA and did not have any indication that approval might be delayed (see this). His comments were made following a recommendation last November by an FDA advisory panel that Tresiba should be approved, but that Novo should conduct a cardiovascular outcomes trial in 7,500 patients with type 2 diabetes – after approval. By issuing a complete response letter, however, the FDA is signaling a desire to avoid the possibility that safety issues could emerge with a primary care drug after facing a firestorm ove...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Diabetes Insulin Novo Nordisk Sanofi Triseba Source Type: blogs