Amylin Pharmaceuticals and Eli Lilly today announced that the New Drug Application for exenatide has been accepted for review by the Food and Drug Administration.
Exenatide is the first potential therapy in a new class of drugs under investigation for the treatment of type 2 diabetes known as incretin mimetics. The NDA for exenatide was submitted to the FDA on June 29, 2004. The Prescription Drug User Fee Act goal date is April 30, 2005.
"This is an important step in the regulatory process as we work to transition exenatide from an investigational agent to the marketplace, providing an additional therapy to people living with type 2 diabetes," said Ginger Graham, President and CEO of Amylin Pharmaceuticals.
The exenatide NDA is made up of three major components; chemistry and manufacturing, preclinical and clinical. The clinical component of the submission is based on 30-week data from three blinded pivotal trials of exenatide involving more than 1,400 patients who were unable to control their blood sugar on common oral therapies including metformin, sulfonylurea or a combination of both. The submission also includes 52-week open-label data from the extensions of these pivotal studies and from an additional open-label study.