References in periodicals archive
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Orphan Drug Designation for Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy
PON1 decreases lipid peroxide accumulation in LDL due to its antioxidant ability against hydroperoxides thus reduce LDL and phospholipid oxidation, Thus, PON1 may be involved against atherosclerosis protection.1 Diabetes mellitus (DM), is a life-threatening chronic disease associated with about 10% death episodes in adults.2 DM is leading risk factor for development of coronary heart diseases and mortality if not properly managed.3 In recent meta-analysis study that involved 35 studies worldwide, PON1 has been shown to decrease in DM and to be associated with the risk of diabetic macroangiopathy and microangiopathy.4 In addition, in another meta-analysis, PON1 polymorphisms have been shown to play an important role in the susceptibility of diabetic macroangiopathy and microangiopathy.5
Akari Therapeutics PLC (NASDAQ: AKTX) said the FDA has granted orphan drug designation for its namocopan for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Namocopan also has Fast Track designation for the same indication in pediatric patients.
Food and Drug Administration has granted Fast Track designation for nomacopan for the treatment of hematopoietic stem cell transplant associated thrombotic microangiopathy in pediatric patients.
Omeros is preparing to submit a biologics license application and a marketing authorization application to the US Food and Drug Administration and to the European Medicines Agency, respectively, for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
The dermatologic diagnosis with the highest 30-day same-cause readmission rate was vascular hamartomas at 21.1%, followed by dermatomyositis (18.3%) and thrombotic microangiopathy (13.7%).
The product is intended to treat people with aHUS, a disease of the red blood cells, and inhibition of complement-mediated thrombotic microangiopathy. It is said to be the first and only long-acting C5 inhibitor administered every eight weeks and it works by inhibiting the C5 protein in the terminal complement cascade.
No evidence of thrombotic microangiopathy was present.
NEW YORK, N.Y., March 13, 2019 -- Akari Therapeutics, Plc (AKTX) announced that it completed a successful Type B, pre-IND meeting with the FDA regarding a proposed clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
The alveolar-capillary network in the lung is a large microvascular unit and may be affected by microangiopathy. [3] The major morbidities in type 2 diabetes are due to its microangiopathic and macroangiopathic complications.
The involvement of kidney vessels is called renal microangiopathy and it plays an important role in diabetic nephropathy.
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