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

Stock marketsEU

29.01.2015 Denmark's Ascendis Pharma has successfully raised US$108m with its upsized NASDAQ IPO, while Irish animal health specialist Nexvet is waiting in the wings.

Contract ResearchEU

28.01.2015 EMA recommends suspending around 750 generic medicines marketed throughout the world after India’s GVK Biosciences is accused of faking bioequivalence studies. Meds considered critically important for patients will remain available.

RegulationEU

21.01.2015 The EMA is asking for comments on how to implement the transparency rules of EU Clinical Trial Regulation, pointing to the new clinical trial portal and database as the main instrument.

Stock marketsEUGermany

21.01.2015 2014 was a record year for biotech companies on the European stock market, with a total of €2.4bn raised in the year - 25% more than in the year before.

ResearchEUUK

20.01.2015 Ebola research projects are set to receive €215m in funding from the European Commission’s IMI2 Ebola+ programme. Among the project partners are vaccine developers Glaxosmithkline, Johnson&Johnson and Merck. 

Stock ExchangeUKDenmarkFrance

16.01.2015 It's time to get used to weekly IPO plans by European biotechs. UK's drug discovery firm Redx Pharma Ltd, established just five years ago, has come of age with their £80m (€105m) IPO plans.

M&ASwitzerland

14.01.2015 Pharma kingpin Roche has launched a billion-dollar transaction for a total of US$1.2bn (€1bn), taking over the majority of US cancer specialist Foundation Medicine.

PoliticsEU

14.01.2015 The European Parliament has backed the legislation allowing individual countries to restrict or prohibit the cultivation of genetically modified crops that have been authorised at EU level.

M&AIrelandUK

13.01.2015 Shire beefs up its rare disease portfolio after acquiring NPS Pharma with the aim of becoming a leading biotech in a US$5.2bn deal. Part of the deal is the US biotech's lead portfolio of gastrointestinal and hormone replacement therapies.

M&ASwitzerlandFrance

09.01.2015 The excitement surrounding CRISPR genome editing shows no sign of abating. This month, Novartis and US biotech Intellia Therapeutics became the first ever biotech-pharma collaboration to use the groundbreaking technology.

Events

All Events

Current issue

All issues

Product of the week

Products

Stock list

All quotes

TOP

  • FORMYCON13.90 EUR12.10%
  • MAGFORCE5.10 EUR7.82%
  • SANTHERA103.00 CHF5.64%

FLOP

  • CYTOS0.32 CHF-17.95%
  • CO.DON2.15 EUR-4.44%
  • MEDIGENE3.80 EUR-4.28%

TOP

  • ADDEX3.44 CHF48.3%
  • CYTOS0.32 CHF39.1%
  • FORMYCON13.90 EUR37.9%

FLOP

  • ACTELION100.70 CHF-13.3%
  • BIOFRONTERA2.02 EUR-12.2%
  • MOLOGEN5.72 EUR-9.9%

TOP

  • SANTHERA103.00 CHF2494.5%
  • BB BIOTECH248.45 EUR95.9%
  • FORMYCON13.90 EUR85.3%

FLOP

  • CYTOS0.32 CHF-91.2%
  • MOLOGEN5.72 EUR-50.5%
  • 4SC0.82 EUR-50.0%

No liability assumed, Date: 28.01.2015