Novo Nordisk (OMX: NOVO B) announced tonight that it has received a complete response letter from the US Food and Drug Administration pertaining to the NDA of insulin degludec (Tresiba®) and insulin degludec/insulin aspart (Ryzodeg®). The company is asked to deliver additional data from a dedicated trial looking into cardiovascular outcomes.
Novo expressed disappointment and surprise and says it will not be able to provide such data within 2013. It is now evaluating the response and will work with the agency regarding the path forward. The products are approved in various locations such as EU and Japan. Novo will host a conference call tomorrow at 8 AM CET on this clearly material setback.
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