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GSK gets EU approval for labelling update to Relvar Ellipta in patients with asthma

Published 09 March 2018

GlaxoSmithKline has received approval from the European Commission for a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting β2-agonist (LABA) combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting β2-agonist.

The Type II variation regulatory approval has been supported by data from a non-inferiority lung function study, which demonstrated that patients with adequately controlled asthma were able to switch to the once-daily FF/VI 100/25, from the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50, without compromising their lung function.

 No new safety signals were identified and the adverse event data were consistent with the known safety profile for FF/VI established in patients with asthma.

GSK global respiratory franchise head and SVP Jonathan Sweeting said: "Patients with asthma can continue to experience symptoms despite being adequately controlled and these symptoms can impact their lives.

“This label update gives doctors the option of switching appropriate patients from their current ICS/LABA to once-daily Relvar Ellipta.”

Innoviva chief scientific officer and senior vice president Dr. Theodore J. Witek Jr said: “The evidence supporting this regulatory update means doctors can be confident that patients taking once-daily Relvar Ellipta will experience comparable benefit in lung function and safety profile, as with a twice-daily ICS/LABA. We welcome this approval, which signifies an important milestone for Relvar Ellipta.”

The updated marketing authorisation by the European Commission will be reflected in the label for Relvar Ellipta for countries in the European Union.

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily life.

The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

Relvar Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting β2-agonist, in a single inhaler, the Ellipta®.

Relvar Ellipta is indicated in Europe for 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; patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.



Source: Company Press Release