Dexlansoprazole, a New Dual-Delayed Release Technology for the Treatment Of Reflux Disease, Accepted for National Approvals Within the European Union

News provided by

Takeda Pharmaceuticals Europe Ltd

19 Dec, 2013, 08:30 GMT

ZURICH, December 19, 2013 /PRNewswire/ --

Takeda Pharmaceuticals International GmbH ("Takeda") announced that the European decentralised procedure (DCP) was positively concluded for dexlansoprazole, a proton pump inhibitor (PPI) with a new dual-delayed release technology for the treatment of reflux disease. The regulatory process has now entered into the national phase in which the involved member states can adopt a national decision and grant national marketing authorization. Sweden was the first country to approve dexlansoprazole in the EU, followed by Lithuania, Belgium, Germany and Ireland. Takeda anticipates further national approvals and market launches from Q4 FY13.

The application for marketing authorization in 16 countries through the DCP was submitted in March 2012 with Portugal serving as its Reference Member State (RMS). Following its evaluation, the RMS and all Concerned Member States (CMS) reached consensus that dexlansoprazole is approvable.

Common symptoms of reflux disease are persistent heartburn and regurgitation, i.e. pain or burning in the chest, stomach acid rising into the esophagus, sour taste in the mouth and burning in the throat. The prevalence of reflux disease has been increasing in the last 20 years[1] and affects up to 25% of people in Europe.[2]

Dexlansoprazole is the first and only currently approved PPI with a dual-delayed release formulation and that relieves GERD symptoms for up to 24 hours.[3],[4] The PPI can be taken without regard to food intake[5] or the timing of meals.[6],[ 7]

Dexlansoprazole has been approved in adults for the treatment of erosive reflux esophagitis, the maintenance of healed erosive reflux esophagitis and maintenance of relief of heartburn as well as for short-term treatment of heartburn and acid regurgitation associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).[7] The most frequently reported side effects include diarrhoea, abdominal pain, headache, feeling sick (nausea), abdominal discomfort, gas (flatulence) and constipation.[7]

Dexilant® was approved by the FDA (Food and Drug Administration) in the US in 2009 for the management of erosive esophagitis and non-erosive reflux disease. It is also marketed in Canada, Mexico and several countries in Asia.

With the approval of dexlansoprazole in Europe, Takeda expands its profile in the Gastrointestinal area as an innovative and ethical company producing medicine that improves people's lives.

Other PPIs marketed by the Takeda Group include: pantoprazole, marking more than 15 years of experience and over one billion treatment courses.[8] Pantoprazole is marketed in more than 90 countries under a variety of brand names, including Pantozol®. Takeda also markets Tecta®, the improved pantoprazole magnesium formulation and lansoprazole, a well-known PPI in around 90 markets.

About Takeda Pharmaceuticals International GmbH

Headquartered in Zurich as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Osaka, Japan, the company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus include cardiovascular and metabolic, oncology, respiratory and immunology, central nervous system, general medicine, and vaccines.

Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda is available through its corporate website, http://www.takeda.com.

References:

  1. El-Serag HB. Clin Gastroenterol Hepatol 2007; 5: 17-26
  2. El-Serag HB et al. Gut Published Online 13 July 2013; doi: 10.1136/gutjnl-2012-304269
  3. Metz DC, et al. Aliment Pharmacol Ther 2009;29:742-54;
  4. Howden CW, et al. Aliment Pharmacol Ther 2009;30:895-907.
  5. Lee RD, et al. Aliment Pharmacol Ther 2009;29:824-33.
  6. Lee RD, et al. Aliment Pharmacol Ther 2010;31:1001-11.
  7. EU Summary of Product Characteristics, Dexilant®, September 2013
  8. Periodic Safety Update Report (PSUR) No. 34 - pantoprazole, October 2012

This press release has been issued by Takeda Pharmaceuticals International GmbH, Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon, Zurich, Switzerland.

Contacts:
Danny Stepto
Takeda Pharmaceuticals International GmbH
+41(0)44-555-1504
danny.stepto@takeda.com