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GlaxoSmithKline's Relvar Ellipta gets updated label in EU
GlaxoSmithKline and its partner Innoviva announced on Thursday that the European Commission has approved a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI).
The FTSE 100 drugmaker said Relvar Ellipta is an inhaled corticosteroid and long-acting β2-agonist combination, with the label update for patients whose asthma was already adequately controlled on both an inhaled corticosteroid and long-acting β2-agonist.
It said the Type II variation regulatory approval was 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) 250/50, without compromising their lung function.
No new safety signals were identified, and the adverse event data was said to be consistent with the known safety profile for FF/VI established in patients with asthma.
"Patients with asthma can continue to experience symptoms despite being adequately controlled and these symptoms can impact their lives," said GlaxoSmithKline senior vice-president and head of global respiratory franchise Jonathan Sweeting.
"This label update gives doctors the option of switching appropriate patients from their current ICS/LABA to once-daily Relvar Ellipta."
Dr Theodore J Witek Jr, senior vice-president and chief scientific officer of Innoviva, added that the evidence supporting the regulatory update meant doctors could be confident that patients taking once-daily Relvar Ellipta would 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," Dr Witek added.
The updated marketing authorisation by the European Commission would be reflected on the label for Relvar Ellipta for countries in the European Union.