Diamyd Medical has received highly encouraging feedback from the U.S. Food and Drug Administration (FDA) regarding an Accelerated Approval pathway for its innovative immunotherapy, Diamyd®, which is designed to treat patients with Stage 3 Type 1 Diabetes carrying the HLA DR3-DQ2 genotype. In a recent in-person Type C Meeting, the FDA acknowledged that C-peptide levels could be used by Diamyd Medical as a surrogate endpoint reasonably likely to predict the clinical benefit of preserving endogenous insulin production. This significant acknowledgment means that Accelerated Approval could be sought based on demonstrating substantial treatment-related benefits on C-peptide levels in response to Diamyd® administration.
Diamyd Medical is actively engaged in ongoing discussions with the FDA to determine the precise requirements for submitting a Biologics License Application (BLA) under the Accelerated Approval pathway. These discussions will include exploring the potential for an earlier readout of stimulated C-peptide levels from the ongoing Phase 3 trial, DIAGNODE-3. This trial aims to confirm the efficacy and safety of Diamyd® in preserving insulin production among newly diagnosed patients.
“Aligning with the FDA on the pathway for Accelerated Approval for Diamyd® represents a significant step towards making this groundbreaking treatment available to patients with type 1 diabetes,” said Ulf Hannelius, CEO of Diamyd Medical. “The potential of using C-peptide as a surrogate endpoint for accelerated approval marks an important milestone in our efforts. We are committed to working closely with the FDA to diligently advance on this pathway and to obtain regulatory approval as soon as possible for this promising therapy. Our goal is to provide an effective treatment that can significantly improve the quality of life for patients and potentially alter the course of the disease.”
Optimism Surrounds Diamyd® Following Positive FDA Feedback on Accelerated Approval
Professor Mark Atkinson, PhD, a Diamyd Medical Board Member and an investigator with four decades of experience in efforts to prevent and reverse type 1 diabetes, expressed his optimism following the FDA meeting. “I left this FDA meeting with an extreme sense of optimism that a pathway for approval is feasible for Diamyd®. The need for such a therapy clearly exists, and the real winners of any such decision, if afforded, will be those living with type 1 diabetes, and perhaps even those who have yet to be diagnosed. This feedback from the FDA is a testament to the potential impact Diamyd® could have on the diabetes community.”
The FDA instituted its Accelerated Approval Program to allow for the earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required before receiving FDA approval, allowing patients faster access to potentially life-saving therapies. This program is particularly valuable for conditions like type 1 diabetes, where timely intervention can make a significant difference in patient outcomes.
Type 1 Diabetes Breakthrough as Diamyd Medical Pursues Accelerated Approval for Diamyd®
Diamyd Medical’s pursuit of Accelerated Approval for Diamyd® highlights the innovative approaches being employed to address the urgent needs of patients with type 1 diabetes. By using C-peptide as a surrogate endpoint, Diamyd Medical aims to demonstrate that Diamyd® can preserve the body’s ability to produce insulin, thus delaying the progression of the disease and improving the quality of life for patients. This approach not only expedites the drug approval process but also underscores the potential of Diamyd® to become a cornerstone therapy in the management of type 1 diabetes.
Diamyd Medical is dedicated to developing precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd® is an antigen-specific immunomodulatory therapeutic designed to preserve endogenous insulin production. It has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2, and 3 Type 1 Diabetes.
The DIAGNODE-3 confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes in eight European countries and the U.S. Significant results have previously been shown in a large genetically predefined patient group, both in a large-scale meta-analysis and in the company’s prospective European Phase IIb trial.
Resource: Diamyd Medical, July 23, 2024
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