US FDA accepts Tresiba and Ryzodeg resubmissions for review

The US Food and Drug Administration) has accepted for review Danish diabetes care giant Novo Nordisk’s (NOV: N) Class II Resubmissions for its ultra long-acting insulins Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), the company revealed late yesterday.

To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review on matters related to the interim analysis.

As previously communicated, the result of an interim analysis 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 derived from the interim analysis is thus only an indication of the final trial results. Novo Nordisk management does not have access to the results of the interim analysis. The trial is expected to be completed in the second half of 2016.

Commercial outlook

Pharma industry analysts forecast Tresiba will generate annual sales of $2.2 billion by 2020, according to consensus estimates compiled by Thomson Reuters Cortellis. A US launch within the next year may help Tresiba see off rivals, most notably French drug major Sanofi's (Euronext: SAN) Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), which is intended to replace its soon to lose patent protection blockbuster Lantus (insulin glargine), and was approved by the FDA earlier this year (The Pharma Letter February 26).