The European Commission has granted marketing authorization for Anoro (Umeclidinium/Vilanterol), a chronic obstructive pulmonary disease (COPD) treatment, which is currently licensed in Europe as UMEC/VI55mcg/22mcg. GlaxoSmithKline and Theravance announced the now-authorized combination treatment is a once-daily maintenance bronchodilator that relieves the principal symptoms of COPD in adult patients. The effect is achieved by the combination of two bronchodilators, umeclidinium (UMEC) a long-acting muscarinic antagonist, and vilanterol (VI) a long-acting beta2 agonist, both in a single inhaler called Ellipta.
The European marketing authorization for UMEC/VI treatment included a review of eight phase III clinical trials, in which 6,000 COPD patients participated. A total of 1,296 patients received the recommended dose of UMEC/VI55/22mcg once daily with endpoint of improving the disease’s symptoms.
The launch of this treatment is expected for Q2-3 2014 in Europe. Additional launches will follow thereafter. It is expected that this new treatment will be able to help the 4-10% of the European population that suffer with COPD, which includes chronic bronchitis, emphysema, or both.
“There are many people across Europe living with COPD who experience a variety of symptoms and for whom the disease represents a significant burden. GSK is committed to developing a range of new therapeutic options that provide physicians with treatment choices when considering individual patient needs,” Darell Baker, SVP & Head, GSK Global Respiratory Fanchise said. “We are delighted by today’s marketing authorisation for Anoro Ellipta which provides a new alternative for COPD patients for whom dual bronchodilator treatment in a single inhaler may be appropriate”
Rick E. Winningham, Chief Execitive officer of theravance said “We are very pleased that Anoro Ellipta is now licensed across 31 European countries for the treatment of COPD. We believe this will be an important treatment option for appropriate patients with COPD and is a further positive outcome from the collaboration between Theravance and GSK to bring to market new respiratory medicines that meet patient needs.”
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