Click here to close now.

SYS-CON MEDIA Authors: Elizabeth White, XebiaLabs Blog, Liz McMillan, David Sprott, Carmen Gonzalez

News Feed Item

GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum™ (albiglutide)

LONDON, April 15, 2014 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1), is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle. Glucagon-like peptide-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent.

Vlad Hogenhuis, Senior Vice-President and Head, GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, said: "Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels. We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US."

The FDA approval of albiglutide is based on the results of GSK's comprehensive Phase III Harmony programme, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment. 

Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014. 

Albiglutide was licensed by the European Medicines Agency in March 2014, under the brand name Eperzan®, for use in adult patients with type 2 diabetes.

About diabetes
Diabetes is a global epidemic, affecting 382 million individuals globally, over 20 million of whom are in the US.1 Up to 95% of these patients have type 2 diabetes.1 Type 2 diabetes is a life-long, progressive and, in some cases, preventable condition characterized by high blood sugar levels, known as hyperglycemia.  A lack of physical activity, obesity, increasing age, high blood pressure and genetics are known risk factors that can contribute to the development of type 2 diabetes.2,3  Treatment options include lifestyle changes such as increased physical activity and diet but, as the condition progresses, patients may require the addition of oral and injectable medications to control blood sugar levels and, ultimately, the use of insulin, either daily or with meals.

About Tanzeum (albiglutide)
Tanzeum is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

LIMITATIONS OF USE
Tanzeum is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Tanzeum has not been studied in patients with a history of pancreatitis. Tanzeum is not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Tanzeum has not been studied in patients with pre-existing severe gastrointestinal disease. Tanzeum has not been studied in combination with prandial insulin.

Full US Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use will soon be available at us.gsk.com.  Prior to the label being posted online, a copy of the label may be requested from the GSK Media or Investor Relations contacts listed in the "GlaxoSmithKline Inquiries" section at the end of this document.

Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis.  A non-promotional factsheet, reviewed by the FDA, with more detailed safety information is available at www.TANZEUMREMS.com.

Important Safety information for Tanzeum (albiglutide)
The following information is taken from the highlights section of the US Prescribing Information.  Please see full Prescribing Information including boxed warning.

BOXED WARNING: RISK OF THYROID C-CELL TUMORS

Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

CONTRAINDICATIONS
Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components.

WARNINGS AND PRECAUTIONS
Pancreatitis: Discontinue promptly if suspected. Do not restart if confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycemia: Can occur when used in combination with insulin secretagogues (e.g. sulfonylureas) or insulin. Consider lowering sulfonylurea or insulin dosage when starting Tanzeum.

Hypersensitivity Reactions: Discontinue Tanzeum if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve.

Renal Impairment: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Macrovascular Outcomes: There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with Tanzeum or any other antidiabetic drug.

ADVERSE REACTIONS
Adverse reactions, reported in >/=10% of patients treated with Tanzeum and more frequently than in patients on placebo, were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.

Tanzeum and Eperzan® are trademarks of the GlaxoSmithKline group of companies.

GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

References

  1. IDF. Diabetes Atlas. Sixth Edition. 2013. Available at: http://www.idf.org/diabetesatlas/download-book. Last accessed April 2014
  2. Elbein SC. Genetics Factors Contributing to Type 2 Diabetes across Ethnicities. Diabetes Sci Technol. 2009 July; 3(4): 685–689.
  3. IDF. Types of diabetes. 2013. available at: http://www.idf.org/types-diabetes. Last accessed April 2014.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.

Registered in England & Wales:

No. 3888792


Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

SOURCE GlaxoSmithKline plc

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that Creative Business Solutions will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Creative Business Solutions is the top stocking authorized HP Renew Distributor in the U.S. Based out of Long Island, NY, Creative Business Solutions offers a one-stop shop for a diverse range of products including Proliant, Blade and Industry Standard Servers, Networking, Server Options and...
WHOA.com has announced the newest addition to its data center footprint with the expansion into Equinix's newest state-of-the-art facility: DC-11 Washington, DC IBX+. Located in Ashburn, VA, this data center expands Whoa.com's presence to meet rapidly expanding customer demand for secure cloud solutions. Equinix, Inc. operates International Business Exchange™ (IBX®) data centers in 32 markets across 15 countries in the Americas, EMEA, and Asia-Pacific. Equinix is committed to operating faciliti...
SYS-CON Events announced today that FierceDevOps will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. FierceDevOps keeps software developers and IT operations personnel updated on the latest news and trends around the rapidly evolving role of the traditional IT worker.
The Open Compute Project is a collective effort by Facebook and a number of players in the datacenter industry to bring lessons learned from the social media giant's giant IT deployment to the rest of the world. Datacenters account for 3% of global electricity consumption – about the same as all of Switzerland or the Czech Republic -- according to people I met at the recent Open Compute Summit in San Jose. With increasing mobility at the edge of the cloud and vast new dataflows being pre...
GENBAND has announced that SageNet is leveraging the Nuvia platform to deliver Unified Communications as a Service (UCaaS) to its large base of retail and enterprise customers. Nuvia’s cloud-based solution provides SageNet’s customers with a full suite of business communications and collaboration tools. Two large national SageNet retail customers have recently signed up to deploy the Nuvia platform and the company will continue to sell the service to new and existing customers. Nuvia’s capabili...
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborat...
WSM International is launching a DevOps services division that offers assessment, consulting and implementation to large enterprises and organizations with complex infrastructures. This is the first independent services company to create a dedicated practice to help organizations looking to transition to the DevOps model. The concept of DevOps is to blend information technology (IT) software development with operations to optimize the computing infrastructure according to the specific needs of ...
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Temasys has announced senior management additions to its team. Joining are David Holloway as Vice President of Commercial and Nadine Yap as Vice President of Product. Over the past 12 months Temasys has doubled in size as it adds new customers and expands the development of its Skylink platform. Skylink leads the charge to move WebRTC, traditionally seen as a desktop, browser based technology, to become a ubiquitous web communications technology on web and mobile, as well as Internet of Things...
Modern Systems announced completion of a successful project with its new Rapid Program Modernization (eavRPMa"c) software. The eavRPMa"c technology architecturally transforms legacy applications, enabling faster feature development and reducing time-to-market for critical software updates. Working with Modern Systems, the University of California at Santa Barbara (UCSB) leveraged eavRPMa"c to transform its Student Information System from Software AG's Natural syntax to a modern application lev...
Today, IT is not just a cost center. IT is an enabler and driver of business. With the emergence of the hybrid cloud paradigm, IT now has increasingly more capabilities to create new strategic opportunities for a business. Hybrid cloud allows an organization to utilize multi-tenant public clouds, dedicated private clouds, bare metal hosting, and the associated support and services for the right use cases through an on-demand, XaaS model. This model of IT creates tremendous opportunities for busi...
Hosted PaaS providers have given independent developers and startups huge advantages in efficiency and reduced time-to-market over their more process-bound counterparts in enterprises. Software frameworks are now available that allow enterprise IT departments to provide these same advantages for developers in their own organization. In his workshop session at DevOps Summit, Troy Topnik, ActiveState’s Technical Product Manager, will show how on-prem or cloud-hosted Private PaaS can enable organ...
In today's digital world, change is the one constant. Disruptive innovations like cloud, mobility, social media, and the Internet of Things have reshaped the market and set new standards in customer expectations. To remain competitive, businesses must tap the potential of emerging technologies and markets through the rapid release of new products and services. However, the rigid and siloed structures of traditional IT platforms and processes are slowing them down – resulting in lengthy delivery ...
Business as usual for IT is evolving into a “Make or Buy” decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud busi...