SOURCE: Horizon Pharma plc DUBLIN, IRELAND--(Marketwired - Oct 3, 2014) - Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company with a portfolio of products in arthritis, inflammation and orphan diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for ACTIMMUNE (Interferon gamma-1b) for the treatment of Friedreich's ataxia (FA), a rare, genetic disease for which there are currently no approved treatments. The U.S. Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition that affects fewer than 200,000 patients in the United States. Orphan designation qualifies the sponsor of the drug for various development incentives, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan-drug designation is not subject to the Prescription Drug User Fee Act (PDUFA) fees. The designation may provide ACTIMMUNE, if approved for the treatment of FA, with seven years of market exclusivity for this indication. FA is a debilitating, life-shortening, degenerative neuro-muscular disorder that affects about one in 50,000 people in the United States. Onset of symptoms can vary from five years old to adulthood, with the childhood … Continue reading →

Many of those who are genetically predisposed to develop atrial fibrillation, which dramatically raises the risk of stroke, can be identified with a blood test. This is shown by new research from Lund University in Sweden. The number of people affected by atrial fibrillation is rising rapidly, partly as a result of the ageing population. Over recent years, a research group at Lund University in Sweden, working with other universities and hospitals in Europe and the USA, has identified twelve genetic variants in the human genome that increase the risk of atrial fibrillation. The research group has now studied the possible clinical benefits of a DNA test: One in five people have a genetic weakness that means they have twice as high a risk of developing atrial fibrillation as those with a low genetic risk. This genetic risk is therefore one of the strongest risk factors for atrial fibrillation that we know of in people without overt cardiac disease. It increases the risk as much as high blood pressure, for example, said Olle Melander, Professor of Internal Medicine, and Gustav Smith, Associate Professor in Cardiology, both from Lund University. Since the symptoms of atrial flutter can be weak and unclear, … Continue reading →

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