Novo's new insulin Tresiba to face tough questions from FDA panel

Last week, the future of Novo Nordisk's new insulin drug Tresiba looked very bright. Today, not so much.

A week ago, the European Medicines Agency (EMA) recommended the long-acting insulin for approval, and before that Japan had approved the new treatment. But late Thursday, the company pointed to a document that indicates that an FDA panel evaluating the drug wants to focus on cardiovascular risks when it takes up the topic Nov. 8.

The news kicked the air out of Novo Nordisk's ($NVO) shares, which were trading down as much 5% in early trading, Reuters reports. Novo, and investors, have big expectations for Tresiba, which has the generic name insulin degludec. Natixis Securities analysts recently called the drug the "key to future growth'" for Novo. Analysts say sales could reach $9 billion in 2016, according to Bloomberg.

The delay is, of course, good for Sanofi ($SNY). Its Lantus stands to be undermined the most by Tresiba. Lantus dominates the long-acting insulin market with sales of about $5.1 billion for 2011. It has grown 17% so far this year, with a tad more than $3 billion in first-half sales. Novo has data from a head-to-head study against Lantus which shows Tresiba performing better at preventing nighttime blood sugars from falling too precipitously.

For all of its big expectations, the road to potential approval in the U.S. has been very difficult so far. Consideration of the drug has already been delayed a couple of times. Bloomberg reports today that Jeffrey Holford, an analyst with Jefferies & Co., has notified investors that he thinks there is a 70% percent chance approval will be tied to Novo having to conduct a new study on cardiovascular risks. But Alistair Campbell, an analyst at Berenberg Bank, didn't rule out the possibility that approval could be delayed for years by the FDA asking for another study before approval.

- here's the Reuters story
- and the Bloomberg story
- check out FierceBiotech's take
- here's the FDA document

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