Click here to close now.

SYS-CON MEDIA Authors: Liz McMillan, Pat Romanski, William Schmarzo, Elizabeth White, Carmen Gonzalez

News Feed Item

Lexicon's LX4211 - FDA canagliflozin Decision is Key Bellweather

DUBLIN, January 29, 2014 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/2qlc2k/lexicons_lx4211) has announced the addition of the "Lexicon's LX4211 - FDA canagliflozin decision is key bellweather" report to their offering. 

     (Logo: http://photos.prnewswire.com/prnh/20130307/600769 )


LX4211 is part of a new class of type 2 diabetes agents that inhibit the SGLT2 glucose transporter, thereby blocking reabsorption of glucose that the kidneys have excreted into the urine. However, it is distinct from its predecessors in the class in that it also inhibits SGLT1, another glucose transporter that facilitates the absorption of dietary glucose from the gut. 

The regulatory pathway for a competing SGLT2 inhibitor (BMS/AZN' dapagliflozin) has been somewhat rocky and the PDUFA for another of these agents (J&J's canagliflozin) is eminent (March 31, 2013), which should provide important regulatory signals for LX4211 as well. 

This report explores the underlying pharmacology of these agents, available clinical data, and the regulatory landscape and its risks. In doing so, it attempts to answer two basic questions: Will LX4211 gain regulatory approval and will it be able to gain market share vs competitors? 

Key Topics Covered: 

INTRODUCTION

1. Type-2 diabetes
2. Sodium glucose transport (SGLT) inhibition as a new approach to therapy

LX4211 CLINICAL DATA

1. Phase I studies evaluated three forms, dose timing, and drug interactions
2. Study 201 assessed activity over 28 days
3. Study 202: A phase IIb study of LX4211 with metformin background therapy
4. Other studies planned and in progress

CLINICAL AND REGULATORY DISCUSSION

1. What does the pharmacology tell us about potential benefits and risks?

  • Basic science data illuminate the potential impact of SGLT inhibition
  • Genetic deletions/mutations of glucose transporters may mimic effects of inhibition

2. Early LX4211 data are consistent with the proposed pharmacology

3. What does dapagliflozin tell us about SGLT2 inhibition and FDA's views?

  • Preclinical toxicology and early human pharmacology studies
  • Efficacy
  • Safety
  • The current status

4. Does the more recent canagliflozin experience add further relevant insight?

  • Efficacy
  • Safety
  • In conclusion

5. What does FDA guidance teach us about the path forward?

  • General guidance for diabetes therapies
  • Diabetes drugs and cardiovascular risk

6. What are the take-away' lessons for LX4211 from these two programs?

  • Efficacy
  • Safety

MARKET ISSUES

1. Overview

  • Epidemiology
  • Revenues provide another window into the diabetes market
  • Prescription shares provide another view of the diabetes market

2. Pipeline

3. Where does this leave LX4211?

SUMMARY OPINION 

Author 

  • Dr. Ellen Brady
  • Dr. Ilana Fogelman


For more information visit http://www.researchandmarkets.com/research/2qlc2k/lexicons_lx4211


Media Contact: Laura Wood , +353-1-481-1716, [email protected]


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
The consumption economy is here and so are cloud applications and solutions that offer more than subscription and flat fee models and at the same time are available on a pure consumption model, which not only reduces IT spend but also lowers infrastructure costs, and offers ease of use and availability. In their session at 15th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed this shifting dynamic with an ...
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackI...
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT transformation?
You use an agile process; your goal is to make your organization more agile. But what about your data infrastructure? The truth is, today's databases are anything but agile - they are effectively static repositories that are cumbersome to work with, difficult to change, and cannot keep pace with application demands. Performance suffers as a result, and it takes far longer than it should to deliver new features and capabilities needed to make your organization competitive. As your application an...
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises a...
The recent trends like cloud computing, social, mobile and Internet of Things are forcing enterprises to modernize in order to compete in the competitive globalized markets. However, enterprises are approaching newer technologies with a more silo-ed way, gaining only sub optimal benefits. The Modern Enterprise model is presented as a newer way to think of enterprise IT, which takes a more holistic approach to embracing modern technologies.
SYS-CON Events announced today that SUSE, a pioneer in open source software, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SUSE provides reliable, interoperable Linux, cloud infrastructure and storage solutions that give enterprises greater control and flexibility. More than 20 years of engineering excellence, exceptional service and an unrivaled partner ecosystem power the products and support that help ...
Move from reactive to proactive cloud management in a heterogeneous cloud infrastructure. In his session at 16th Cloud Expo, Manoj Khabe, Innovative Solution-Focused Transformation Leader at Vicom Computer Services, Inc., will show how to replace a help desk-centric approach with an ITIL-based service model and service-centric CMDB that’s tightly integrated with an event and incident management platform. Learn how to expand the scope of operations management to service management. He will al...
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impac...
There's no doubt that the Internet of Things is driving the next wave of innovation. Google has spent billions over the past few months vacuuming up companies that specialize in smart appliances and machine learning. Already, Philips light bulbs, Audi automobiles, and Samsung washers and dryers can communicate with and be controlled from mobile devices. To take advantage of the opportunities the Internet of Things brings to your business, you'll want to start preparing now.
In a world of ever-accelerating business cycles and fast-changing client expectations, the cloud increasingly serves as a growth engine and a path to new business models. Dynamic clouds enable businesses to continuously reinvent themselves, adapting their business processes, their service and software delivery and their operations to achieve speed-to-market and quick response to customer feedback. As the cloud evolves, the industry has multiple competing cloud technologies, offering on-premises ...
As the world moves from DevOps to NoOps, application deployment to the cloud ought to become a lot simpler. However, applications have been architected with a much tighter coupling than it needs to be which makes deployment in different environments and migration between them harder. The microservices architecture, which is the basis of many new age distributed systems such as OpenStack, Netflix and so on is at the heart of CloudFoundry – a complete developer-oriented Platform as a Service (PaaS...
T-Mobile has been transforming the wireless industry with its “Uncarrier” initiatives. Today as T-Mobile’s IT organization works to transform itself in a like manner, technical foundations built over the last couple of years are now key to their drive for more Agile delivery practices. In his session at DevOps Summit, Martin Krienke, Sr Development Manager at T-Mobile, will discuss where they started their Continuous Delivery journey, where they are today, and where they are going in an effort ...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
There is no question that the cloud is where businesses want to host data. Until recently hypervisor virtualization was the most widely used method in cloud computing. Recently virtual containers have been gaining in popularity, and for good reason. In the debate between virtual machines and containers, the latter have been seen as the new kid on the block – and like other emerging technology have had some initial shortcomings. However, the container space has evolved drastically since coming on...