The drugmaker AstraZeneca PLC said Wednesday it has submitted a new drug application to U.S. authorities and applied for marketing clearance from European authorities for its Onglyza diabetes treatment.
Astra made the submissions to the U.S. Food and Drug Administration and the European Medicines Agency, a significant step in what analysts consider to be a potential new blockbuster drug for the company, with its partner Bristol-Myers Squibb Co.
The program is slightly behind schedule — Astra had previously said it would submit a marketing application by the first half of the year.
The two companies began collaborating in January 2007 to develop and sell two investigational drugs for type 2 diabetes, saxagliptin and dapagliflozin.
The applications announced Wednesday are for saxagliptin, following clinical trials of the drug. Onglyza is the companies' proposed trade name.
The announcement came a day before Bristol-Myers announces its quarterly earnings results. AstraZeneca gives a third quarter update on July 31.
