BFW 04/07 19:42 *NOVO NORDISK US FDA TO REVIEW TRESIBA® & RYZODEG® RESUBMISSIONS
BN 04/07 19:42 *NOVO NORDISK US FDA TO REVIEW TRESIBA® & RYZODEG® RESUBMISSIONS
BN 04/07 19:42 *NOVO NORDISK A/S: US FDA ACCEPTS TRESIBA®, RYZODEG®
BN 04/07 19:42 *NOVO NORDISK US FDA TO REVIEW TRESIBA® & RYZODEG® RESUBMISSIONS
BN 04/07 19:42 *NOVO NORDISK A/S: US FDA ACCEPTS TRESIBA®, RYZODEG®
Novo Nordisk A/S: US FDA accepts Tresiba® and Ryzodeg® resubmissions for review
2015-04-07 19:42:05.809 GMT
Bagsværd, Denmark, 7 April 2015 - Novo Nordisk today announced that the US
Food and Drug Administration (FDA) has accepted for review the Clas
II Resubmissions for Tresiba^® (insulin degludec) and Ryzodeg^® (insulin
degludec/insulin aspart).
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.
For further information
Media:
Katrine Sperling +45 3079 6718 krsp@novonordisk.com
Ken Inchausti (US) +1 609 514 8316 kiau@novonordisk.com
Investors:
Kasper Roseeuw Poulsen +45 3079 4303 krop@novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com
Daniel Bohsen +45 3079 6376 dabo@novonordisk.com
Frank Daniel Mersebach (US) +1 609 235 8567 fdni@novonordisk.com
Company announcement No 26 / 2015
Company announcement No 25 / 2015
2015-04-07 19:42:05.809 GMT
Bagsværd, Denmark, 7 April 2015 - Novo Nordisk today announced that the US
Food and Drug Administration (FDA) has accepted for review the Clas
II Resubmissions for Tresiba^® (insulin degludec) and Ryzodeg^® (insulin
degludec/insulin aspart).
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.
For further information
Media:
Katrine Sperling +45 3079 6718 krsp@novonordisk.com
Ken Inchausti (US) +1 609 514 8316 kiau@novonordisk.com
Investors:
Kasper Roseeuw Poulsen +45 3079 4303 krop@novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com
Daniel Bohsen +45 3079 6376 dabo@novonordisk.com
Frank Daniel Mersebach (US) +1 609 235 8567 fdni@novonordisk.com
Company announcement No 26 / 2015
Company announcement No 25 / 2015