Reuters: Regulatory News: UPDATE 1-Europe backs new dual-action Novartis lung drug

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UPDATE 1-Europe backs new dual-action Novartis lung drug Jul 26th 2013, 12:18 Fri Jul 26, 2013 8:18am EDT LONDON, July 26 (Reuters) - Swiss drugmaker Novartis won an important endorsement of its new inhaled medicine for chronic lung disease on Friday when European regulators recommended approval of Ultibro Breezhaler. Also known as QVA149, the once-daily medicine belongs to a new type of dual-action treatments that are expected by analysts to become major sellers and is the first in the class to win such a green light. It contains two bronchodilators - indacaterol, a long-acting beta2-adrenergic agonist (LABA), and glycopyrronium, a long-acting muscarinic antagonist (LAMA). Other companies including GlaxoSmithKline are also working to develop such combinations. The European Medicines Agency (EMA) said it had also recommended a new HIV medicine from Gilead Sciences called Tybost, or cobicistat, a drug that does not itself fight the virus that causes AIDS but boosts the function of other HIV medicines. The European recommendation contrasts with a rebuff for the Gilead product from U.S. regulators in April. In addition, the EMA issued a positive opinion for Gentium's drug Defitelio for use in patients undergoing blood stem-cell transplantation, and Boehringer Ingelheim's lung cancer drug Giotrif. GSK's Revolade was recommended for wider use in patients with thrombocytopenia associated with chronic hepatitis C infection, while Bayer's Eylea was backed for wider use in eye disease. However, Otsuka's new drug Delamanid for treating multidrug-resistant tuberculosis was not recommended for approval. Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. Link this Share this Digg this Email Reprints

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