The FDA has approved a new inhaler for patients with chronic obstructive pulmonary disease (COPD).
GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved ANORO™ ELLIPTA™ as a combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) 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 Ellipta (umeclidinium and vilanterol inhalation powder) is the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: “We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD. It is the first combination product approved in the US that delivers two once-daily bronchodilators in a single inhaler. This approval is a significant achievement for GSK.”
“We are very pleased that Anoro Ellipta has become the first once-daily dual bronchodilator approved in the US for the treatment of COPD,” said Rick E Winningham, Chief Executive Officer of Theravance. “This is a significant milestone for Theravance and GSK and is testament to our ongoing partnership and shared commitment to the development of respiratory medicines.”
Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the first quarter of 2014. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million (USD) to GSK following FDA approval of Anoro Ellipta. A further $30 million (USD) payment to GSK will follow the launch of Anoro Ellipta in the US.
The phase III pivotal programme for Anoro Ellipta included seven clinical studies with almost 6,000 patients with COPD.