Novo Nordisk’s new insulin candidate Tresiba has been recommended for approval in the US, just a few days after getting a similar green light in Europe.
Novo will have to carry out a cardiovascular outcomes trial with Tresiba (insulin degludec), but this will not need to be conducted ahead of registration. Novo is now predicting approval of the once-daily basal insulin analogue in the US in the first half of 2013.
An FDA advisory committee voted eight to four in favour of approving Tresiba (insulin degludec) and a combination product called Ryzodeg (insulin degludec and insulin aspart) with a post-approval outcomes trial commitment.
Novo Nordisk shares rose on the announcement, having been depressed of late after it emerged that the FDA panel would focus on the cardiovascular risk profiles of the two products, as well as claimed benefits such as a lower risk of hypoglycaemia than currently-marketed basal insulins including Sanofi’s €4bn-a-year blockbuster Lantus (insulin glargine).
Sanofi currently dominates the long-acting insulin market but Novo has said it aims to be the major player in the category within next several years.
Outside the US, the progress of Tresiba through the regulatory route seems to be on track. Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Tresiba in September and Novo is currently in the process of negotiating price with the Japanese authorities prior to launch, with a chance of getting the drug to market there within a couple of months and with premium pricing.
Meanwhile, in Europe, Tresiba and Ryzodeg were recommended by the EMA in October and formal approval is expected within the next few weeks. Both products have also been given a green light in Mexico.
Analysts have predicted that Tresiba could bring in sales of $2bn to $4bn within the next few years, with projections varying depending on how physicians weigh up the cardiovascular risk profile versus Tresiba’s advantages in terms of providing stable and predictable insulin cover.