DANBURY, Conn. The Food and Drug Administration has turned down an application for an insulin product made by Biodel, Biodel said.
The drug maker announced that it received a complete response letter from the FDA for Linjeta (human insulin [rDNA origin]) for the treatment of Type 1 and Type 2 diabetes.
Acomplete response letter means that the FDA has completed review of an application, but questions remain that preclude final approval. Specifically, the FDA brought up issues surrounding data from a trial of Type 1 diabetes patients in India and the insulin’s noninferiority compared with other treatments in Type 2 diabetes patients.
“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,” Biodel president and CEO Errol De Souza said. “We remain committed to the development of an ultra-rapid acting injectable insulin to address an important unmet need for patients with diabetes.”