Pharmaprojects R&D Pipeline News Feed
Positive outlook for long-acting Exenatide
08 Apr 2009
A Phase III meta-analysis of primary cardiovascular events associated with exenatide (Byetta) has been successfully completed, showing no associated increase in risk of cardiovascular events. This will support a planned US NDA submission for the long acting formulation, exenatide-once weekly, in the 2nd quarter of 2009. Exenatide is a synthetic version of naturally-occurring exendin-4, isolated from the Gila monster lizard, which was developed by Amylin for the treatment of Type II diabetes. The long-acting formulation of Exenatide is under joint development by Alkermes, Amylin and Eli-Lilly. Following this positive result Lilly and Amylin plan to initiate a much larger global study to determine whether there are any favourable cardiovascular effects of exenatide therapy.
The results of this study are increasingly significant in light of the recent history of the diabetes therapy field. In 2007 the US FDA issued a black box warning for the big-selling drug rosiglitazone (Avandia) regarding potential cardiovascular risks in Type II diabetes patients with underlying heart disease or high risk of heart attack. Since then diabetes drugs have been subject to even greater scrutiny regarding cardiovascular risks, with long-term cardiovascular safety assessment now a requirement. This ranges from conducting additional Phase IV trials, to more robust design and data collection in Phase II and III trials. Diabetes drugs now face even more obstacles on the path to approval.
If approved, exenatide-once weekly may have the potential to reduce excess cardiovascular morbidity and mortality associated with Type II diabetes. Completed Phase III trials have already shown significant glycaemic improvements in this patient population, with no major adverse events, and importantly it has been shown to reduce the weight of patients, and therefore reduce one cardiovascular risk factor. An additional Phase III trial (Duration-5) in 240 Type II diabetics is now underway, to demonstrate superiority of exenatide-once weekly compared with exenatide, and will be used to support filings outside of the US.
