STOCKHOLM, July 18,
2024 /PRNewswire/ -- Diamyd Medical announced
today that the U.S. Food and Drug Administration (FDA) has granted
Fast Track designation for Diamyd® (rhGAD65/alum)
to treat Type 1 Diabetes in pediatric patients with Stage 1 or
Stage 2 Type 1 Diabetes carrying the genotype HLA DR3-DQ2. Earlier
this year, Diamyd® received Fast Track designation for
the treatment of individuals with Stage 3 Type 1 Diabetes carrying
the HLA DR3-DQ2 genotype. The FDA grants Fast Track designation to
facilitate the development and expedite the review of medicines to
treat serious conditions and fill an unmet medical need. Fast Track
designation is intended to bring promising medicines to patients
sooner.
"We are thrilled to receive our second Fast Track designation
for Diamyd, this time for its potential to delay the onset of
clinically diagnosed type 1 diabetes", says Ulf Hannelius, CEO of Diamyd Medical. "This
recognition once again underscores the potential of our precision
medicine approach and the urgent need for new treatment options for
type 1 diabetes across the disease spectrum. We now have the
opportunity to work closely with the FDA to accelerate the
development of Diamyd also as a preventive medicine."
For further information regarding Fast Track drug development
programs, please refer to the Guidance for Industry: Expedited
Programs for Serious Conditions - Drugs and Biologics at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
Staging of Type 1 Diabetes - Opportunity for Prevention and
Early Intervention
Type 1 Diabetes (T1D) is a chronic autoimmune disease that attacks
the insulin producing beta cells in the pancreas. The onset of T1D
starts months to years before symptomatic disease and is divided
into disease stages. Individuals with Stage 1 T1D have tested
positive for two or more diabetes-related autoantibodies but still
have normal blood glucose values and no symptoms of the disease.
Individuals with Stage 2 T1D have progressed to abnormal blood
glucose values (so-called dysglycemia) but are otherwise
asymptomatic. Stage 3 T1D is synonymous with clinically diagnosed
Type 1 Diabetes.
Diamyd Medical develops treatments for all stages of T1D. The
target population for the DiaPrecise trial comprises individuals
with Stages 1 T1D or Stage 2 T1D, whilst individuals with Stage 3
T1D (i.e. clinically diagnosed T1D) are the target population for
the pivotal Phase III trial DIAGNODE-3 with the antigen-specific
immunotherapy Diamyd®.
About Diamyd Medical
Diamyd Medical develops 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 for the
preservation of endogenous insulin production that 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. DIAGNODE-3, a confirmatory Phase III trial
is actively recruiting patients with recent-onset (Stage 3)
Type 1 Diabetes in eight European countries and in the US.
Significant results have previously been shown in a large
genetically predefined patient group - in a large-scale
meta-analysis as well as in the Company's prospective European
Phase IIb trial, where Diamyd® was administered
directly into a superficial lymph node in children and young adults
with recently diagnosed Type 1 Diabetes. Injections into a
superficial lymphnode can be performed in minutes and are intended
to optimize the treatment response. A biomanufacturing facility is
under development in Umeå, Sweden,
for the manufacture of recombinant GAD65 protein, the active
ingredient in the antigen-specific immunotherapy
Diamyd®. Diamyd Medical also develops the GABA-based
investigational drug Remygen® as a component in the
treatments of metabolic diseases. Diamyd Medical is a major
shareholder in the stem cell company NextCell Pharma AB and in the
artificial intelligence company MainlyAI AB.
Diamyd Medical's B-share is traded on Nasdaq First North Growth
Market under the ticker DMYD B. FNCA Sweden AB is the Company's
Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
E-mail: ulf.hannelius@diamyd.com
This information was brought to you by Cision
http://news.cision.com
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SOURCE Diamyd Medical AB