Research & Development
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
15 February 2024 -

Swedish biotechnology company Diamyd Medical AB (STO:DMYD-B) announced on Thursday that the US Food and Drug Administration (FDA) has granted Fast Track designation for Diamyd (rhGAD65/alum), targeting improved glycaemic control in recently diagnosed stage 3 Type 1 Diabetes patients with the genotype HLA DR3-DQ2.

Fast Track status expedites development and review processes for medicines addressing critical needs, aiming to benefit patients sooner.

CEO Ulf Hannelius welcomed the FDA's decision, emphasising the opportunity to accelerate Diamyd's entry into the US market. Type 1 diabetes, a progressive autoimmune condition, affects millions globally, necessitating innovative treatment approaches.

Diamyd represents a pivotal step towards personalised medicine in Type 1 diabetes treatment, offering hope beyond traditional insulin therapy. The urgency for novel therapies is evident due to the limitations of current treatments in achieving glycaemic targets and preventing complications.

Clinical trials have demonstrated Diamyd's potential to preserve pancreatic beta cell function and enhance glycaemic control safely. The ongoing Phase III trial, DIAGNODE-3, focuses on individuals recently diagnosed with Type 1 Diabetes with the HLA DR3-DQ2 genotype.