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June 16, 2014
08:04 EDTLGNDLigand says LGD-6972 well-tolerated in Phase 1 study
Ligand Pharmaceuticals announced data from a Phase 1 clinical trial with LGD-6972 that demonstrate favorable safety, tolerability and pharmacokinetics in normal healthy volunteers and in subjects with type 2 diabetes mellitus, and also demonstrate a robust response on fasting plasma glucose after a single dose. LGD-6972 is Ligandís novel glucagon receptor antagonist and these first-in-human data were presented at the American Diabetes Associationís 74th Scientific Sessions meeting underway in San Francisco. Highlights of the single-ascending dose trial involving a total of 56 subjects include: LGD-6972 was well-tolerated; there were no clinically significant or dose-dependent changes in hematology, clinical chemistry, urinalysis, ECG or vital signs, and no serious adverse events. LGD-6972 was well-absorbed after oral administration; peak plasma concentrations were reached approximately 5 to 8 hours post dose with a long elimination half-life of approximately 50 hours, supporting once-daily dosing. After a single dose, LGD-6972 reduced fasting plasma glucose in normal healthy volunteers and in subjects with type 2 diabetes. Fasting plasma glucose was reduced by 57 mg/dL in subjects with type 2 diabetes, suggesting a robust response in this acute study.
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August 24, 2015
13:15 EDTLGNDFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

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