GlaxoSmithKline and Theravance have announced that they have received marketing authorization for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD in Europe. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issues a positive opinion regarding Anoro in February 2014.
The approval triggers a $15 million milestone payment from Theravance to GSK. According to the companies, the first launch of the product in Europe will take place in the 2nd or 3rd quarter of this year.
GSK Global Respiratory Franchise Senior VP and Head Darrell Baker commented, “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 authorization for Anoro Ellipta which provides a new alternative for COPD patients for whom dual bronchodilator treatment in a single inhaler may be appropriate.”
Theravance CEO Rick E Winningham added, “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.”
Anoro Ellipta was launched in the US in April 2014.
Read the GSK/Theravance press release.
