Relvar Ellipta for the treatment of asthma and COPD, approved in Europe


European Commission has granted marketing authorisation for Relvar Ellipta, which is now licensed across 31 European countries for the following uses: a) asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product ( long-acting beta2-agonist and inhaled corticosteroid ) is appropriate: patients not adequately controlled with inhaled corticosteroids and as needed inhaled short-acting beta2-agonists; b) COPD: the symptomatic treatment of adults with chronic obstructive pulmonary disease with a FEV1less than 70% predicted normal ( post-bronchodilator ) with an exacerbation history despite regular bronchodilator therapy.

Relvar is a combination of the inhaled corticosteroid ( ICS ), Fluticasone furoate ( FF ), and the long-acting beta2-agonist ( LABA ), Vilanterol ( VI ) [ FF/VI ].
Two strengths of FF/VI have been licensed for the treatment of asthma ( 92/22 mcg and 184/22 mcg ) and one strength has been licensed for the treatment of COPD ( 92/22 mcg ). Both strengths are administered once-daily using Ellipta, a new dry powder inhaler ( DPI ).

In Europe, the FF/VI strengths of 92/22 mcg and 184/22 mcg are specified as the delivered doses ( emitted from the inhaler ). The lower strength is equivalent to the 100/25 mcg pre-dispensed dose ( contained inside the inhaler ) and the higher strength is equivalent to the 200/25 mcg pre-dispensed dose.

Asthma is a chronic lung disease that inflames and narrows the airways, causing recurring periods of wheezing, chest tightness, shortness of breath and coughing which often occurs at night or early in the morning. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.
The causes of asthma are not completely understood however key risk factors are inhaled substances that provoke allergic reactions or irritate the airways. These include smoke and allergens like dust mites and pets.

Chronic obstructive pulmonary disease is a term referring to two lung diseases, chronic bronchitis and emphysema, that are characterised by obstruction to airflow that interferes with normal breathing. 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. COPD-related exacerbations are typically defined as a worsening of symptoms that require medical intervention. ( Xagena )

Source: GSK, 2014

XagenaMedicine2014