STOCKHOLM ,
July 23,
2024 /PRNewswire/ -- Diamyd Medical received
encouraging feedback from the U.S. Food and Drug Administration
(FDA) regarding an Accelerated Approval pathway for its
immunotherapy, Diamyd®, for treating patients with
Stage 3 Type 1 Diabetes carrying the genotype HLA DR3-DQ2.
In a recent in-person Type C Meeting, the FDA acknowledged that
C-peptide could be used by Diamyd Medical as a surrogate endpoint
reasonably likely to predict the clinical benefit of preservation
of endogenous insulin production. As such, Accelerated Approval
could be sought based on a demonstration of significant
treatment-related benefits on C-peptide levels in response to
Diamyd®
administration. Diamyd Medical has and will continue to have
ongoing discussions with the FDA to determine the requirements for
a Biologics License Application (BLA) under an Accelerated Approval
pathway, including a potential earlier readout of stimulated
C-peptide from the ongoing Phase 3 trial DIAGNODE-3.
"Aligning with the FDA on the pathway for Accelerated Approval
for Diamyd represents a significant step towards making this
treatment available to patients with type 1 diabetes," says
Ulf Hannelius, CEO of Diamyd
Medical. "The potential of using C-peptide as a surrogate endpoint
for accelerated approval marks an important milestone. 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."
Professor Mark Atkinson, PhD,
Diamyd Medical Board Member and an investigator with four decades
of efforts seeking attempts to prevent and reverse type 1 diabetes,
noted, "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."
About Accelerated Approval and Surrogate Endpoints
The FDA instituted its Accelerated Approval Program to allow for
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 prior to receiving FDA approval.
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
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SOURCE Diamyd Medical AB