News

EU approves Sanofi’s Lyxumia
Enlarge image

RegulatoryEUFranceDenmark

EU approves Sanofi’s Lyxumia

05.02.2013 - The European Commission has granted EU market authorisation to Sanofi’s GLP-1 receptor agonist licisenatide as a diabetes therapy.

The first in class once-daily prandial GLP-1 (glucagon-like peptide-1) receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as a second line therapy. The decision of the Commission to approve the drug for patients that do not respond to a combination of oral glucose-lowering medicinal products plus basal insulin as well as diet and exercise is based on results from the GetGoal clinical programme

In 11 studies on 5,000 patients, the Paris-based drug maker demonstrated significant HbA1c reductions, a pronounced post-prandial glucose lowering effect and a beneficial effect on body weight in adult patients with type 2 diabetes. GetGoal results also showed that Lyxumia (licisenatide) had a favourable safety and tolerability profile in most patients, with mild and transient nausea and vomiting, the most common adverse events observed in the GLP-1 receptor agonist class, and a limited risk of hypoglycaemia, according to Sanofi.

The therapy, which was licensed from Danish Zealand Pharma A/S in a €170m deal, is indicated when first-line therapy proves no longer effective over time. It strengthens Sanofi’s leading position in the €12bn diabetes market. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells

© eurobiotechnews.eu/tg 

http://www.european-biotechnology-news.com/news/news/2013-01/eu-approves-sanofis-lyxumia.html

FinancingBelgium

28.04.2015 After having raised €100m in its stock market debut, MDx company Biocartis has gained 13 percent on its first trading day.

R&DFranceUKSweden

24.04.2015 AstraZeneca has boosted its oncology portfolio by signing a US$1.275bn agreement with Innate Pharma. The companies plan to further the development of Innate’s tumour-targeting antibody.

PoliticsEU

22.04.2015 A legislative proposal by the European Commission is set to renationalise market authorisation of genetically modified crops.

FinancingUK

21.04.2015 Ahead of its listing on the London Stock Exchange, Woodford’s Patient Capital Trust has raised a record sum of €1.1bn. The fund met with immense interest by investors.

Swiss Biotech DaySwitzerland

16.04.2015 The Swiss biotech industry can look back on 2014 as a good year, but political uncertainties do remain. This was one of the topics discussed during the Swiss Biotech Day in Basel, which attracted more than 400 participants.

EventEUFrance

16.04.2015 The changing landscape in healthcare was just one of the hotly discussed topics of the 27th Annual EuroMeeting of the international association DIA.

R&DBelgium

14.04.2015 Belgian Thrombogenics NV has launched a new oncology company with Gent-based life sciences institute VIB. The new venture will develop an antibody for the treatment of a fast-growing brain tumour that affects children and adolescents.

Stock MarketsEUFranceUKNorwaySweden

09.04.2015 The European public markets remain highly attractive for biotech companies. Twice as many companies went public in the first quarter of 2015 than during the same period last year.

FinancingAustriaUKSwitzerlandGermany

08.04.2015 To bring its lead product of a new class of antimicrobials to phase 3 trials, Nabriva Therapeutics has completed a US$120m Series B financing.

Research & DevelopmentNetherlands

07.04.2015 Gene therapy is attracting more and more big pharma companies. Now, Bristol-Myers Squibb has forged a US$1bn collaboration with Dutch uniQure, also picking up a 4.9% share in the company.

Events

All Events

Partner-Events

München

BioVaria 2015

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • WILEX4.84 EUR34.82%
  • FORMYCON31.25 EUR11.61%
  • PAION2.76 EUR6.98%

FLOP

  • MEDIGENE12.41 EUR-3.42%
  • SANTHERA96.75 CHF-2.12%
  • MOLOGEN5.01 EUR-1.18%

TOP

  • WILEX4.84 EUR63.5%
  • FORMYCON31.25 EUR35.0%
  • CO.DON3.35 EUR29.8%

FLOP

  • CYTOS1.08 CHF-22.9%
  • BIOTEST78.40 EUR-18.9%
  • THERAMETRICS0.07 CHF-12.5%

TOP

  • SANTHERA96.75 CHF2368.1%
  • CYTOS1.08 CHF671.4%
  • WILEX4.84 EUR469.4%

FLOP

  • MOLOGEN5.01 EUR-55.5%
  • BIOFRONTERA2.40 EUR-26.8%
  • THERAMETRICS0.07 CHF-22.2%

No liability assumed, Date: 27.04.2015