March 27, 2015
By Alex Keown, BioSpace.com Breaking News Staff
BAGSVAERD, Denmark -- Danish-based Novo Nordisk , the world’s largest insulin maker, will resubmit its new drug application of its insulin treatment Tresiba and related drug Ryzodeg to the U.S. Food and Drug Administration (FDA) after interim analysis of the drug’s cardiovascular effects, the company announced Thursday.
Analysts told Bloomberg Business that resubmission to regulatory authorities suggests the data in the analysis does not suggest a risk of increased heart risks, which could put the drug in line for approval in the United States sometime in 2016. The diabetes-treatment is already marketed outside the U.S., including Denmark, Mexico, the United Kingdom, Japan, Switzerland and Sweden.
Resubmission based on the interim analysis is expected to take place within a month, Novo Nordisk said. Waiting for full results of the trial could have pushed resubmission plans back until next year, causing the company to lose out on sales in one of the largest drug markets in the world. Following the resubmission announcement shares of Novo Nordisk (NVO) were trading heavily for as much as $54.38 per share. Currently the stock is trading at $53.25, up $3.42 from Friday’s opening of $49.53 per share.
Tresiba is a once-daily long-lasting insulin treatment, also known as degludec, that the company believes will be a huge driver in diabetes treatments.
The FDA rejected Tresiba in 2013 due to concerns of increased risk of heart complications. The FDA asked the Novo Nordisk to complete a cardiovascular safety study of the long-acting insulin in 7,500 patients before granting market authorization. The FDA’s rejection came on the heels of Tresiba’s approval by European regulatory authorities.
Following the FDA rejection, Novo Nordisk initiated new cardiovascular risk trial, dubbed DEVOTE. In a press release the company said preliminary analysis from the DEVOTE trial “carries a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations. Accordingly, the relative risk estimate that has been derived from the interim analysis is thus only an indication of the final trial results.”
In addition to the data from the interim analysis of DEVOTE, the Class II Resubmission will include a safety update including data from all clinical trials with insulin degludec, as well as an overview of post-marketing data, the company said.
Following the submission, the FDA is expected to communicate either its acceptance of the filing or issue a so-called incomplete response letter within a month. A rival to Tresiba from Sanofi , Lantus insulin, generated $6.91 billion in sales last year, The Street reported. Sanofi has another insulin product in its pipeline, Toujeo, which is expected to succeed Lantus.
If Tresiba is approved in the U.S., industry analysts forecast annual sales of $2.2 billion by 2020, Reuters reported. In December Novo Nordisk announced the European Committee for Medicinal Products for Human Use issued a positive opinion for expanded use of Tresiba in children and adolescents ages 1 to 17 years with diabetes.
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