Fast Track for Type 1 Diabetes Drug

FDA has granted Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in recently diagnosed Stage 3 Type 1 diabetes patients with the genotype HLA DR3-DQ2. Antigen-specific therapy Diamyd is currently being evaluated in what the company calls the first-ever precision medicine Phase 3 trial in Type 1 diabetes (DIAGNODE-3), and it “represents a significant shift towards personalized medicine” for treating diabetes.

The shift toward precision medicine is due to the “inadequacy of current treatment options that are characterized by a failure to consistently achieve glycemic targets as well as the prevalence of short- and long-term complications,” Diamyd says. “In clinical trials, Diamyd has demonstrated the potential to specifically and safely modulate the immune system’s response against pancreatic beta cells, aiming to halt or slow the disease’s progression,” it says.