If the FDA approves the once-weekly diabetes treatment exenatide (Bydureon) later this year, it may quickly face some strong competition from new drugs now in the pipeline, according to a review presented by Alan Garber of Baylor College of Medicine in Houston.
Writing from the World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension in Prague, the peer-reviewed MedPageToday highlights taspoglutide--which is now in Phase III--as well as albiglutide and LY2189265, which are in mid-stage studies. These drugs have been modified to keep them in circulation for days, Garber notes, rather than hours. And because the new exenatide will have to be injected with a rather large needle, patients are likely to be on the lookout for a less painful treatment.
While Garber notes that the health benefits of exenatide LAR appear to be enhanced, so are the adverse events linked to the therapy. "Some 35% of patients taking exenatide LAR developed antibodies during the first months of treatment, about twice as many as seen with the twice-daily version," he says. "In both cases, antibody titers dropped with continued treatment, and only a minority of antibodies appeared to deactivate the agent in vitro."
Garber also reviewed the ambitious late-stage development plan for taspoglutide, with eight studies involving 6,000 patients. Just a few weeks ago Roche announced that taspoglutide performed well in its first Phase III trial, and analysts expect to see a 2011 regulatory filing in Europe and the U.S.
The FDA noted back in March that Bydureon wasn't ready for approval, but didn't require Amylin, Eli Lilly and Alkermes to mount any new trials. The FDA set a PDUFA date of October 22 for the therapy, with plans to clarify manufacturing processes, prescribing information and a risk evaluating and mitigation study.
- here's the report from MedPageToday