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Anoro® (umeclidinium/vilanterol) gains marketing authorisation in Europe for the treatment of COPD

GlaxoSmithKline plc and , Inc. have announced that the European Commission has granted for Anoro® (umeclidinium/vilanterol) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease ().

Anoro is a once-daily combination treatment comprising two bronchodilators, umeclidinium (), 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 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 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.”

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.

For the EU Summary of Product Characteristics for Anoro, please visit: http://ec.europa.eu. Prior to the prescribing information being posted online, a copy may be requested from one of the GSK Media or Investor Relations contacts listed in the “GSK Enquiries” section at the end of this document.

About COPD

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.[i]

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]

Important Safety Information for Anoro

The following Important Safety Information is based on a summary of the Summary of Product Characteristics for Anoro. Please consult the full Summary of Product Characteristics for all the safety information for Anoro.

UMEC/VI is contraindicated in patients with hypersensitivity to either umeclidinium, vilanterol, or any of the excipients.

UMEC/VI should not be used in patients with asthma since it has not been studied in this patient population. Administration of UMEC/VI may produce paradoxical bronchospasm that may be life-threatening. UMEC/VI is not indicated for the treatment of acute episodes of bronchospasm.

In the event of deterioration of COPD during treatment with UMEC/VI, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.

Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including UMEC/VI. Patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Therefore, UMEC/VI should be used with caution in patients with severe cardiovascular disease.

Consistent with its antimuscarinic activity, UMEC/VI should be used with caution in patients with urinary retention or with narrow-angle glaucoma.

Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. No clinically relevant effects of hypokalaemia were observed in clinical studies with UMEC/VI at the recommended therapeutic dose of 55mcg/22mcg. Caution should be exercised when UMEC/VI is used with other medicinal products that also have the potential to cause hypokalaemia.

Beta2-adrenergic agonists may produce transient hyperglycemia in some patients. No clinically relevant effects on plasma glucose were observed in clinical studies with UMEC/VI at the recommended therapeutic dose of 55mcg/22mcg. Upon initiation of treatment with UMEC/VI, plasma glucose should be monitored more closely in diabetic patients.

UMEC/VI should be used with caution in patients with convulsive disorders or thyrotoxicosis and in patients who are unusually responsive to beta2-adrenergic agonists.

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take UMEC/VI.

The most frequently reported adverse reaction with UMEC/VI was nasopharyngitis (9%). Other common adverse reactions (reported with a frequency of ?1/100 to <1/10) include: urinary tract infection, sinusitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, constipation and dry mouth.

Other Anoro Ellipta Regulatory Activity:

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. Full US prescribing information, including BOXED WARNING and Medication Guide are available at: http://us.gsk.com/products/assets/us_anoro_ellipta.pdf.

In Europe, the UMEC/VI strength of 55mcg / 22mcg is specified as the delivered dose (emitted from the inhaler) which is equivalent to the 62.5mcg / 25mcg pre-dispensed dose (contained inside the inhaler) authorised in the US and Canada.

Regulatory applications for UMEC/VI have been submitted and are undergoing assessment in a number of other countries, including Japan.

Source

[i] European COPD Coalition. COPD Key Facts. Accessed March 2014. Available at: http://www.copdcoalition.eu/about-copd/key-facts

[ii] National Heart Lung and Blood Institute. Who is at risk for COPD? Accessed March 2014. Available here.

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

Anoro® and Ellipta® are trademarks of the GSK group of companies.

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