Following this year’s American Diabetes Association (ADA) Scientific Sessions and the subsequent FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting on the role of cardiovascular assessment in diabetes drug development, we are updating our type II diabetes market projections. This update first comments on cardiovascular outcomes from intensive glucose control trials presented at the ADA, along with the results of the FDA meeting, followed by a discussion of individual drug presentations at the ADA and revenue model updates. Finally, there is a comprehensive list of data events that were added from the ADA meeting.

While a major feature of the ADA meeting was the competitive landscape for GLP-1 agonists and DPP-4 inhibitors, the FDA advisory committee vote to include at least a screening cardiovascular study prior to approval of diabetes drugs could greatly impact how future market competition plays out, depending on how the agency decides to handle drugs with Phase III programs that are already mostly finished. In addition, while a screening study would be shorter than a more definitive study (which may be required to begin pre-approval), it is likely to still increase development timelines somewhat.

Regarding GLP-1 agonists, the ADA meeting featured updated data on exenatide LAR and important data releases from liraglutide and earlier stage compounds. A major point from the meeting was the vulnerability of the exenatide franchise, though in the short-term, much will depend on whether the FDA allows liraglutide to be approved without further cardiovascular safety data. In addition, if the FDA similarly decides that exenatide LAR does not need further cardiovascular safety data, since Byetta is already on the market, LAR could have a slightly longer time on the market without a weekly injection competitor. Our base case assumption is that liraglutide and exenatide LAR approvals will not be delayed by the need for a screening study.

New data for DPP-4 inhibitors were also released. While data was not necessarily stronger than for currently approved Januvia, new entrants could take significant share. However, particularly due to the outcome of the FDA advisory committee meeting, there is a great deal of uncertainty regarding the regulatory fate of the late stage DPP-4 inhibitors, whose data raised some safety questions. As a result, our base case assumption is that their approval will be delayed.

Finally, we also highlight interesting data from SGLT inhibitors, PPAR gamma agonists, and obesity drugs.

For the full report, please download the PDF version at the top of this page.

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