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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Biodel saying its Linjeta new drug application (NDA) cannot be approved in its present stage.
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In the CRL, the FDA has asked additional information in relation to the Linjeta (human insulin [rDNA origin]) injection 100IU/ml NDA for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control.
The FDA’s CRL includes comments related to clinical trials, statistical analysis and chemistry, manufacturing and controls.
In the CRL, the FDA has requested Biodel to 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.
Following the CRL, Biodel plans to contact the FDA within the coming weeks to request a meeting to discuss the company’s next steps and requirements for approval of Linjeta.
Additionally, the FDA has also requested additional data related to stability and manufacturing.
Biodel president and CEO Errol De Souza said that they plan to meet with the FDA as quickly as possible to discuss the comments in the complete response letter, clarify requests for new information and determine their path forward.