On August 24, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s oral, next generation PI3K Delta inhibitor, TGR-1202, for the treatment of patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, AUG 24, 2016, View Source [SID:1234514703]). TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL. Schedule your 30 min Free 1stOncology Demo! "We are pleased to receive orphan drug designation for TGR-1202. In addition to our composition of matter patent for TGR-1202 which issued earlier this year, the granting of this orphan drug designation offers an additional level of proprietary protection and also may provide us certain other regulatory and financial benefits," said Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. "We continue to be excited about the differentiated safety profile of TGR-1202 over other PI3k delta inhibitors and believe the UNITY-CLL Phase 3 Trial will showcase those differences."
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Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.
Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL usually gets worse slowly and is one of the most common types of leukemia in adults. It often occurs during or after middle age. It is estimated that there are approximately 20,000 new cases of CLL diagnosed each year in the United States.