Pharma Focus Europe

US Partial Clinical Hold on Diamyd® Phase III Trial Lifted by the FDA

Monday, November 28, 2022

Diamyd Medical has announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial, DIAGNODE-3. The trial aims to evaluate the safety and efficacy of Diamyd®, a precision medicine and antigen-specific immunotherapy, in individuals recently diagnosed with type 1 diabetes. With the FDA's decision, DIAGNODE-3 is now approved to commence in the United States.

Ulf Hannelius, CEO of Diamyd Medical, expresses the significance of this milestone for both the company and individuals living with type 1 diabetes. He emphasizes the commitment to advancing DIAGNODE-3 in the U.S. and collaborating closely with investigators and patient groups to ensure that this therapy becomes available to those in need.

The FDA had initially placed a partial clinical hold on the pivotal DIAGNODE-3 trial in September 2021, which temporarily halted its initiation in the United States. Subsequently, multiple interactions took place between Diamyd Medical and the FDA to address the agency's inquiries. With the partial clinical hold lifted, Diamyd Medical will promptly resume engaging with clinical sites and institutional review boards, aiming to incorporate U.S. clinical sites into the trial. Meanwhile, DIAGNODE-3 has already gained approval and is actively enrolling patients in eight European countries.

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