Amylin, Eli Lilly and Alkermes say they will soon file their once-weekly version of the diabetes blockbuster Byetta and have presented data on the standard drug which showed no increased risk of cardiovascular events.

Specifically, Amylin stated that it is on track to file a New Drug Application to US regulators for Byetta LAR (exenatide) by the end of the second quarter. The company and its partners say that analyses to demonstrate comparability of batches of the drug made by Amylin for commercial use and those manufactured by Alkermes for clinical trials have been successfully completed.

This is important given that in November the US Food and Drug Administration rejected data from studies meant to show that Byetta LAR batches made by Alkermes were comparable to those produced at Amylin's Ohio facility. The submission will also include a meta-analysis of its clinical trials for standard injectable Byetta which showed no increased risk of cardiovascular events associated with exenatide use.

Amylin and Lilly also revealed that they intend to initiate a large trial to see if there are any favourable cardiovascular effects of exenatide compared to standard of care with traditional antidiabetes drugs.

Orville Kolterman, senior vice president of R&D at Amylin, said “we are confident that we will have a strong submission package for exenatide once weekly." He added that if approved, Byetta LAR has the potential to become the first weekly therapy to treat type 2 diabetes with glucose control and weight loss.

The filing comes at a time when Byetta sales have slowed after the FDA called for tougher warnings on the drug last year about the risk of acute pancreatitis after two patients died. Also of interest is the upcoming FDA advisory committee meeting (on April 2) of Novo Nordisk’s once-daily injection liraglutide, a glucagon-like peptide-1 analogue like Byetta.

Novo, which will sell the drug as Victoza if approved, is confident of getting the thumbs-up from the FDA. The Danish firm believes its data shows that liraglutide provides statistically significantly better blood glucose control than Byetta and has an excellent safety profile in terms of cardiovascular effects.