Highlighting Women’s Health and Type 1 Diabetes
By Diamyd Medical
Women's health is at the forefront of discussions in 2025, with increasing recognition of the unique challenges faced by women throughout life. Hormonal fluctuations during puberty, menstruation, pregnancy and menopause significantly affect chronic conditions like autoimmune disease like Type 1 Diabetes, with long-term implications for overall well-being.
Navigating the Road to Stable Blood Sugar
For women with Type 1 Diabetes, maintaining stable blood sugar levels is often complicated by hormonal fluctuations. Pregnancy presents additional risks, including preeclampsia and premature birth, requiring close monitoring of both maternal and fetal health. Beyond pregnancy, hormonal changes can exacerbate the risk of long-term complications like cardiovascular disease.
But Type 1 Diabetes is not just a personal challenge—it affects the entire family. Constant monitoring and lifestyle adjustments place a significant emotional and lifestyle burden on patients and loved ones.
This underscores the urgent need for new treatments that can safely and specifically alter the disease course, improving long-term health outcomes for those living with Type 1 Diabetes.
Improving Long-Term Type 1 Diabetes Outcomes
Diamyd Medical, a pioneering biotechnology, is committed to improving the lives of those living with Type 1 Diabetes.
Their investigational treatment, Diamyd®, aims to delay the onset and progression of Type 1 Diabetes by halting the autoimmune destruction of insulin-producing beta cells. This antigen-specific immunotherapy targets individuals with a specific genetic marker (HLA DR3-DQ2) present in up to 40% of Type 1 Diabetes patients, making it a form of precision medicine.
Currently in Phase 3 clinical trials across 60 sites in the U.S. and Europe, Diamyd® has received Fast Track and Orphan designations from the U.S. FDA. An interim readout is planned for March 2026, paving the way for potential accelerated approval in the U.S.
One of the standout aspects of Diamyd® is its favorable safety profile, which may offer a significant advantage over traditional immunosuppressive treatments. Backed by extensive U.S. market research, Diamyd Medical anticipates significant market adoption if approved, with projected peak sales potential exceeding $2 billion.
To support its clinical and commercial goals, Diamyd Medical is building a state-of-the-art biomanufacturing facility in Umeå, Sweden. This facility will scale up the production of recombinant human GAD65 (rhGAD65), the active component in
Diamyd®. The 20,000 square feet facility will enhance production capacity, ensuring quality control and cost efficiency.
Shaping the Future of Type 1 Diabetes Care
Diamyd Medical’s participation in the Bridging the Gap event highlights its commitment to advancing Type 1 Diabetes care. Dr. Karin Rosén, a Board Director at Diamyd Medical, will share her extensive experience in biotechnology, while Ginger Vieira, a Type 1 Diabetes advocate and educator, will offer valuable insights from her lived experience. Dr. Emily K. Sims, a pediatric endocrinologist, will discuss the latest advancements in diabetes treatment.
As Diamyd Medical advances toward potential market approval, its involvement in Bridging the Gap underscores the company’s dedication to transforming Type 1 Diabetes care—not only for women, but for all individuals living with this disease and their families.
