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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]


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