Diamyd Medical has received encouraging feedback from the U.S. Food and Drug Administration (FDA) concerning an Accelerated Approval pathway for its immunotherapy, Diamyd®, designed for Stage 3 Type 1 Diabetes patients with the HLA DR3-DQ2 genotype.

In a recent in-person Type C Meeting, the FDA indicated that Diamyd Medical could use C-peptide levels as a surrogate endpoint to predict the clinical benefits of preserving natural insulin production. This development allows Diamyd® to seek Accelerated Approval based on significant improvements in C-peptide levels due to the treatment. Diamyd Medical will continue discussions with the FDA to establish the requirements for a Biologics License Application (BLA) under this pathway, including the potential for an earlier readout of stimulated C-peptide from the ongoing Phase 3 DIAGNODE-3 trial.

Diamyd Medical, stated, "Aligning with the FDA on the Accelerated Approval pathway for Diamyd is a significant step towards making this treatment available for Type 1 diabetes patients. The use of C-peptide as a surrogate endpoint is a major milestone. We are dedicated to collaborating closely with the FDA to advance this pathway and secure regulatory approval for this promising therapy as soon as possible."

Diamyd Medical and a veteran researcher in Type 1 diabetes, expressed his optimism: "The FDA meeting left me hopeful that a viable approval pathway for Diamyd is within reach. There is a clear need for such a therapy, and any approval would greatly benefit those with Type 1 diabetes, and potentially those who have not yet been diagnosed."

The FDA's Accelerated Approval Program permits earlier approval of drugs for serious conditions with unmet needs based on surrogate endpoints—markers believed to predict clinical benefit, though not direct measures of it. This approach can significantly shorten the time to FDA approval.

 

Source: prnewswire.com

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