GlaxoSmithKline plc (GSK) and Theravance, Inc. announced that the European Commission has granted marketing authorisation for Anoro (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Anoro is a once-daily combination treatment comprising two bronchodilators, umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), in a single inhaler, the Ellipta. The licensed strength in Europe is UMEC/VI 55mcg/22mcg.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, “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. 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.”
“We are very pleased that Anoro Ellipta is now licensed across 31 European countries for the treatment of COPD,” said Rick E Winningham, chief executive officer of Theravance. “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.”
Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15 million (USD) following marketing authorisation for UMEC/VI by the European Commission. A further $15 million (USD) payment to GSK will follow the launch of UMEC/VI in Europe.
The first launch is expected to take place in Europe in Q2-3 2014 with additional launches to follow thereafter.
The EMA assessment of UMEC/VI included a review of eight phase III clinical trials which included over 6,000 COPD patients. Within this, 1,296 patients received the recommended dose of UMEC/VI 55/22mcg once-daily.
COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. COPD is thought to affect 4-10% of the adult population in Europe.
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.ii
Since December 2013, Anoro Ellipta has been licensed for use in appropriate patients with COPD in several countries, including the US and Canada. In the US, Anoro Ellipta is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
Anoro and Ellipta are trademarks of the GSK group of companies.