US FDA accepts Tresiba® and Ryzodeg® resubmissions for review
(Thomson Reuters ONE) -
Bagsværd, Denmark, 7 April 2015 - Novo Nordisk today announced that the US Food
and Drug Administration (FDA) has accepted for review the Class 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(at)novonordisk.com
Ken Inchausti (US) +1 609 514 8316 kiau(at)novonordisk.com
Investors:
Kasper Roseeuw Poulsen +45 3079 4303 krop(at)novonordisk.com
Melanie Raouzeos +45 3075 3479 mrz(at)novonordisk.com
Daniel Bohsen +45 3079 6376 dabo(at)novonordisk.com
Frank Daniel Mersebach (US) +1 609 235 8567 fdni(at)novonordisk.com
Company announcement No 26 / 2015
Company announcement No 25 / 2015:
http://hugin.info/2013/R/1909281/680566.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
[HUG#1909281]
Unternehmensinformation / Kurzprofil:
Datum: 07.04.2015 - 21:42 Uhr
Sprache: Deutsch
News-ID 384101
Anzahl Zeichen: 2400
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
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"US FDA accepts Tresiba® and Ryzodeg® resubmissions for review"
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