The U.S. Food and Drug Administration did not accept Linjeta, Biodel Inc.”™s lead drug candidate for treating diabetes, and the company”™s stock plunged by nearly half in trading prior to the market”™s opening bell Nov. 1.
“We plan to meet with the FDA as quickly as possible to discuss their comments in the complete response letter, clarify their requests for new information and determine our path forward,” said Dr. Errol De Souza, CEO of Danbury-based Biodel, in a prepared statement. “We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes.”
The FDA asked Biodel to conduct two new phase 3 clinical trials to establish the drug candidate”™s efficacy and safety as related to toleration and hypoglycemia, a condition that occurs when blood sugar levels fall too low.
The FDA also requested additional data related to manufacturing, which Biodel plans to outsource to Albany Molecular Research Inc. and to Wockhardt Ltd.
