2013 Diabetes NMEs Span Classes, But Safety Is A Review Issue For All
The repercussions of FDA’s 2008 guidance on cardiovascular risk evaluation in diabetes trials are still being felt in reviews of new agents. Pending applications include two GLP-1 agonists, the third review of a DPP-IV inhibitor, a possible first-in-class SGLT-2 inhibitor and a long-acting basal insulin, and safety is a major review issue for all of them.
You may also be interested in...
J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.
There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.
Eli Lilly and Boehringer Ingelheim announced positive top-line data for a quartet of pivotal trials of their SGLT-2 candidate empagliflozin, while Lilly now will be going it alone on LY2605541, a long-acting insulin.