CHMP provides positive opinion for EU label update for Novo Nordisk's Tresiba® based on data from SWITCH trials
(Thomson Reuters ONE) -
Bagsværd, Denmark, 24 March 2017 - Novo Nordisk today announced that the
Committee for Medicinal Products for Human Use (CHMP), under the European
Medicines Agency (EMA), has issued a positive opinion, recommending an update of
the label for Tresiba(®) (insulin degludec) to include data from the SWITCH 1
and 2 clinical trials. In the trials, Tresiba(®), the new-generation once-daily
basal insulin, demonstrated clinically relevant reductions in hypoglycaemia
compared with insulin glargine U100 in people with type 1 and type 2 diabetes.
For the SWITCH 1 trial, the CHMP recommends the updated label to include results
reflecting the significant reductions in hypoglycaemia. In the trial, adults
with type 1 diabetes treated with Tresiba(®) vs. insulin glargine U100, both in
addition to meal-time insulin aspart, experienced statistically significant
reductions in hypoglycaemia, including 11% reduction of overall symptomatic
hypoglycaemia (severe or blood glucose confirmed), 36% reduction in nocturnal
symptomatic hypoglycaemia and 35% reduction in severe hypoglycaemia during the
trial maintenance period.
For the SWITCH 2 trial, the CHMP recommends the updated label to include results
reflecting the significant reductions in hypoglycaemia. In the trial, adults
with type 2 diabetes treated with Tresiba(®) vs. insulin glargine U100
experienced statistically significant reductions in hypoglycaemia, including
30% reduction in overall symptomatic hypoglycaemia (severe or blood glucose
confirmed) and 42% decrease in nocturnal symptomatic hypoglycaemia, during the
trial maintenance period.
"Following the submission of the application to the EMA in November 2016, we are
very pleased to have received a positive opinion from the CHMP for the label
update already at this point in time," said Mads Krogsgaard Thomsen, executive
vice president and chief science officer at Novo Nordisk. "An inclusion of the
SWITCH trial results in the label will further support the clinical profile of
Tresiba(®)".
The CHMP positive opinion is now referred for final action to the European
Commission, which grants approval in the EU. Novo Nordisk expects to receive the
updated marketing authorisation in the second quarter of 2017.
About Tresiba(®)
Tresiba(®) (insulin degludec) is a once-daily basal insulin that provides
duration of action beyond 42 hours with a flat and stable glucose-lowering
effect. It provides low within-day variability and day-to-day variability and a
lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine
U100. On occasions when administration at the same time of day is not possible,
Tresiba(®) allows for flexibility in day-to-day dosing time with a minimum of
eight hours between injections. Tresiba(®) received its first regulatory
approval in September 2012 and has since been approved in more than 80 countries
globally. It was approved by the FDA in the United States on 26 September 2015.
It is now commercially available in more than 50 countries.
About SWITCH 1 and 2
The two phase 3b, 2x32-week randomised, double-blind, crossover, treat-to-target
trials were initiated to investigate the hypoglycaemia profile of Tresiba(®)
compared to insulin glargine U100 in people with type 1 and type 2 diabetes,
respectively. The primary endpoint was the number of severe or blood glucose
confirmed symptomatic hypoglycaemic episodes observed in participants. The two
secondary endpoints included: the number of severe or blood glucose confirmed
nocturnal episodes experienced in participants; and the proportion of people
with one or more severe hypoglycaemic episodes. In SWITCH 1, 501 people with
type 1 diabetes were randomised to crossover treatment with Tresiba(®) and
insulin glargine U100 in combination with insulin aspart. In SWITCH 2, 721
people with type 2 diabetes were randomised to crossover treatment with
Tresiba(®) and insulin glargine U100 in combination with oral antidiabetic
drugs.
Further information
Media:
Katrine Sperling +45 4442 6718 krsp(at)novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau(at)novonordisk.com
Investors:
Peter Hugreffe Ankersen +45 3075 9085 phak(at)novonordisk.com
Hanna Ögren +45 3079 8519 haoe(at)novonordisk.com
Anders Mikkelsen +45 3079 4461 armk(at)novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj(at)novonordisk.com
Company announcement No 21 / 2017
PR170324_Tresiba_CHMP_recommendation_UK:
http://hugin.info/2013/R/2090414/789394.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 24.03.2017 - 12:30 Uhr
Sprache: Deutsch
News-ID 532309
Anzahl Zeichen: 5454
contact information:
Town:
Bagsvaerd
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 140 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"CHMP provides positive opinion for EU label update for Novo Nordisk's Tresiba® based on data from SWITCH trials"
steht unter der journalistisch-redaktionellen Verantwortung von
Novo Nordisk A/S (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
