Reuters: Hot Stocks: UPDATE 1-FDA panel recommends approval of Glaxo/Theravance lung drug

Reuters: Hot Stocks Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

UPDATE 1-FDA panel recommends approval of Glaxo/Theravance lung drug Apr 17th 2013, 18:51 Wed Apr 17, 2013 2:51pm EDT (Updates with details, share price reaction) By Toni Clarke April 17 (Reuters) - An advisory panel to the U.S. Food and Drug Administration recommended on Wednesday that the agency approve an experimental treatment for smoking-related lung damage made by Britain's GlaxoSmithKline Plc and Theravance Inc. Glaxo's U.S.-traded shares rose 1 percent to $49.92 immediately following the vote. Theravance's shares remained halted shortly after the vote. On Monday, they rose more than 17 percent following a favorable initial review of the drug by FDA staff. The drug, Breo, is an inhaled treatment for chronic obstructive pulmonary disease (COPD), a condition that includes emphysema, chronic bronchitis or both. COPD is the third-leading cause of death in the United States, according to federal data. Breo consists of a corticosteroid, fluticasone furoate, which reduces inflammation, and a novel long-acting beta-agonist, or LABA, called vilanterol, which is designed to open the airways. The product is inhaled through a palm-sized device called Ellipta. Breo, or Relvar as it would be called outside the United States, would compete with, and potentially ultimately supplant, GSK's twice-daily asthma and COPD drug Advair, a roughly $8 billion-a-year drug that contains the steroid fluticasone propionate and the long-acting beta-agonist salmeterol. Breo would also compete with AstraZeneca Plc's twice-a-day Symbicort, an inhaled combination of the corticosteroid budesonide and the long-acting beta-agonist formoterol. Glaxo and Theravance are hoping the once-daily delivery of Breo will make their drug more attractive to patients. The FDA is not obliged to follow the recommendations of its advisory panels, but typically does so. (Reporting By Toni Clarke in Washington; Editing by Gerald E. McCormick and Leslie Adler) Link this Share this Digg this Email Reprints

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions