Biodel Inc. (BIOD) Monday said that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL requesting additional information regarding its new drug application for Linjeta injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.
The CRL stated that the FDA's review cycle is complete and that the application cannot be approved in its present form.
Biodel said it plans to contact the FDA within the coming weeks to request a meeting to discuss its next steps and requirements for approval of Linjeta. The CRL included comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls.
The FDA requested that the company conduct two new phase 3 clinical trials using the commercial formulation, one in patients with type 1 diabetes and the other in patients with type 2 diabetes, to establish efficacy and safety as related to hypoglycemia and toleration.
The FDA also requested additional data related to stability and manufacturing. In addition, the FDA identified resolution of manufacturing issues related to recent site inspections at Hyaluron, Inc. and Wockhardt, Ltd. as a requisite for approval.
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