A Food and Drug Administration (FDA) advisory committee recommended U.S. approval of Anoro Ellipta for long-term maintenance of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The drug, which is a combination of two investigational bronchodilator molecules (umeclidinium/vilanterol) and is administered using the Ellipta inhaler, was developed jointly by GlaxoSmithKline plc (GSK) and Theravance, Inc. Although the FDA does not have to follow the recommendation of its committee, it often does, Reuters reports.
“If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US, marking another significant milestone for GlaxoSmithKline’s portfolio of medicines to treat respiratory disease,” Patrick Vallance, GSK's president of Pharmaceuticals R&D, stated in a press release. “We will continue to work with the FDA as they complete their review.”
Chronic obstructive pulmonary disease is characterized by obstruction to airflow that makes it difficult to breathe. According to the National Heart, Lung and Blood Institute, nearly 12 million adults in the U.S. have COPD while another 12 million are undiagnosed or developing COPD. COPD most often affects people 40 and over who are either current smokers or former smokers. Coughing up mucus is often the first sign of COPD. Chronic bronchitis and emphysema are common names for the disease, which is most usually caused by cigarette smoking. Breathing in other kinds of irritants, like pollution, dust, or chemicals, may also cause or contribute to COPD. Although treatment can make an affected individual more comfortable, there is no cure.
For this reason, it is significant that the advisory committee unanimously approved efficacy data supporting a ‘clinically meaningful benefit’ for a once daily dose in the long-term, maintenance treatment of airflow obstruction in COPD.
“This is a transformative year for Theravance and today's positive recommendation brings the second major respiratory medicine in our GlaxoSmithKline collaboration closer to approval and becoming an important therapeutic option for COPD patients,” Rick E Winningham, chief executive officer of Theravance, stated in a press release.
Theravance, a San Francisco-based company, develops and commercializes small molecule medicines across a number of therapeutic areas, including respiratory disease, bacterial infections, and central nervous system pain. The company often partners with other pharmaceutical companies in its pursuit of drug discovery.
Anoro is an investigational medicine and is not proposed for the relief of acute bronchospasm or for the treatment of asthma in any of the regulatory applications. The clinical development program has involved over 6,000 COPD patients. The most frequently reported side effects of the medication during clinical trials were headache, nasopharyngitis, cough, upper respiratory tract infection, and back pain. COPD exacerbation was the most common serious adverse event reported. Anoro has not yet been approved anywhere in the world, though it is currently under review in Europe and Japan as well as the U.S. The companies aim for FDA approval by Dec. 18 of this year.
Based in the United Kingdom, GlaxoSmithKline focuses on pharmaceuticals, vaccines, and consumer healthcare. The company has a global reach with offices in more than 115 countries. Anoro Ellipta is one of several assets in the company’s respiratory development portfolio, which also includes two other products developed in collaboration with Theravance.