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news.The FDA has granted orphan drug designation to TolerRx's lead product, TRX4, for the treatment of new-onset type 1 diabetes mellitus.
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Orphan drug designation would entitle TolerRx to exclusive marketing rights in the US for seven years should TolerRx be the first company to receive marketing approval for this type of therapeutic drug product. The designation also allows for such benefits as eligibility for research funding, and tax credits for certain research expenses.
In a study of subjects with new-onset type 1 diabetes published in the June 23, 2005 edition of the New England Journal of Medicine, TRX4 was shown to preserve the function of insulin-producing beta cells in the pancreas and reduce the amount of administered insulin needed to control blood glucose levels for at least 18 months after a single six day course of TRX4.
“We are pleased to have received this orphan drug designation for TRX4 in the treatment of new-onset type 1 diabetes,” said Douglas Ringler, CEO of TolerRx. “This designation is one in a number of planned strategic initiatives that will provide us with financial and regulatory benefits and market exclusivity.”