FDA advisory committee text on Tresiba sinks Novo

Novo Nordisk’s (OMX: NOVO B) seemingly unwavering march toward 1000 DKK hit a severe speed bump today. The Danish firm had an all-time high close of 970,50 DKK to end the previous week upon announcing that European regulatory authorities gave a positive opinion on insulin degludec and insulin degludec/insulin aspart once-daily basal insulins (to be known commercially as Tresiba and Ryzodeg). The drugs are expected to compete with the blockbuster Insulin glargine (Lantus) from Sanofi-Aventis (Euronext: SAN, NYSE: SNY, FWB: SNW).

Today Novo was under severe pressure due to a stock exchange notice released after market close on Thursday pointing to a recently published U.S. FDA document relating to an upcoming advisory panel meeting. The document in question was a waiver for a suggested participant so its main purpose was not to disclose information about the topics that are to be covered; those are likely to be released closer to the scheduled date of November 8, but in it was said that meta-analysis of several clinical trials suggests an excess risk for cardiovascular events over comparators. It was also noted there may be a benefit from lower risk of hypoglycaemia than the comparator insulin. Novo Nordisk has previously maintained that the lower risk of nocturnal hypoglycaemia would be the differentiating factor with the competitor while efficacy seems comparable.

Documents brought forward before an advisory panel meeting tend to try to include all the potential major issues to be discussed and sometimes appear more serious for the prospects for an approval than they actually are, but cardiovascular concerns particularly following the well known Avandia case are such that no panellist wants to be blamed for supporting a drug that turns out to have such concerns after the fact. Therefore there is a definite additional uncertainty over approval. The big question is if the panel and later the FDA will opinionate for the need of a cardiovascular study before commercial approval, after it or not at all. The FDA had previously asked for an extension into the review period for Tresiba.