KALAMAZOO, Mich., June 22 /PRNewswire/ — Tolera
Therapeutics, Inc., was granted orphan drug status by the United
States Food and Drug Administration (FDA) for TOL101 (anti-TCR
murine monoclonal antibody, type IgM), for treatment of recent
onset immune-mediated Type 1 diabetes mellitus (T1DM).
Designation is granted for treatment of patients sixteen
years of age and younger with immune-mediated T1DM and preserved
pancreatic beta-cell function, commonly referred to as juvenile
diabetes.
“We are pleased with this designation,” commented John J. Puisis, President and CEO of
Tolera. “Clinicians and patients need an effective and safe
means to modulate the immune system, particularly for juvenile
diabetes patients. Current treatments and industry pipelines
offer very few solutions to advance patient care, leaving these
young patients with a deteriorating disease condition. Thus
far, these treatments can only offset disease symptoms, or slow
disease progression, but at the cost of potentially serious side
effects. We believe we are developing a therapy that will prove to
be both safe and effective, thus providing the patient with a much
better treatment outcome.”
The Orphan Drug Act was enacted to allow the FDA to grant a
product special orphan status when it is intended to treat rare
diseases or conditions — those that affect fewer than 200,000
people annually in the United
States. This special designation waives governmental filing
fees, provides the drug sponsor with tax credits related to
development expenses, as well as other support. In addition,
orphan drug designation creates the opportunity for the sponsor to
apply for orphan drug grant money from the U.S. government to help
support clinical trials. As an agent with the po
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