2013 Diabetes NMEs Span Classes, But Safety Is A Review Issue For All
This article was originally published in Pharmaceutical Approvals Monthly
The repercussions of FDA’s 2008 guidance on cardiovascular risk evaluation in diabetes trials are still being felt in reviews of new agents. CV concerns earned Novo Nordisk’s long-acting basal insulin a “complete response” letter. Pending applications include two GLP-1 agonists and a possible first-in-class SGLT-2 inhibitor, and safety is a major review issue for all of them.
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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.
Bristol suggests FDA has had a change of heart on the evolving filing package for diabetes drug dapagliflozin. Meanwhile, the company sees no additional U.S. regulatory hurdles ahead for the eagerly awaited, novel oral anticoagulant Eliquis.