US FDA requests more cardiovascular data on long-acting insulin products

Source: DIA daily Area: News Novo Nordisk AS has received a Complete Response Letter from the US FDA, requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial before its New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart) can be completed. Novo Nordisk has noted that it would not be able to provide the requested data during 2013.   The FDA has also stated that these approvals cannot be granted until violations cited in a previously announced Warning Letter (issued December 2012) have been resolved. The DIA Daily report suggests that these violations were regarding one of its manufacturing plants.    Tresiba® and Ryzodeg® were approved by the European Commission in January 2013 - please see a related NeLM report at the link below for details.
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news