An experimental diabetes drug from Bristol-Myers Squibb and AstraZeneca met its main target in a late stage study, achieving significant reductions in glycosylated hemoglobin levels.
When added to the common diabetes pill metformin, dapagliflozin cut both levels of both glycosylated hemoglobin -- an indication of glucose levels -- and fasting plasma glucose in patients with type 2 diabetes after 24 weeks, hitting both its main and secondary targets.
It is the first late stage data on the once-daily pill dapagliflozin, a member of a class of drugs known as SGLT2 inhibitors and designed to block reabsorption of glucose to lower elevated blood sugar levels.
If approved, it could be the first such drug to reach the market and the companies have said they could file for approval in late 2010 or early 2011.
In a note earlier this week, analysts at Jefferies estimated peak sales at $1.5 billion but said they were cautious due to potential safety issues, as the drug's mechanism puts excessive pressure on the kidney, and lack of long term data.
We have not seen anything of concern, William Mezzanotte, global product director at Astra, told Reuters. We are confident we can continue safely with this drug.
The trial, results of which were presented at a European Association for the Study of Diabetes (EASD) meeting in Vienna, compared dapagliflozin plus metformin with placebo plus metformin.
An estimated 246 million people globally have diabetes. Most have type 2 diabetes, the kind linked with a poor diet and lack of exercise.
The study assessed results from 546 patients aged 18 to 77 who had type 2 diabetes which was inadequately controlled with metformin alone.
Astra agreed in January 2007 to help develop and sell dapagliflozin and a second Bristol diabetes drug in a deal that could bring the New York-based company more than $1 billion.