GlaxoSmithKline and Innoviva announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending 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.
“There are many asthma patients in Europe who, despite being adequately controlled on a twice-daily ICS/LABA, are still experiencing symptoms or problems with their asthma,” Jonathan Sweeting, SVP and Global Head of Respiratory Franchise GSK, said. “We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients.”
The Type II variation regulatory submission 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.
A positive CHMP opinion is one of the final steps before marketing authorization is updated by the European Commission. A final decision is anticipated towards the end of the first quarter of 2018.
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 in the regular treatment of patients aged 12 and over with asthma, where use of a combination product (long-acting β2–agonist, LABA, and inhaled corticosteroid, ICS) is appropriate: Patients not adequately controlled on both ICS and 'as-needed' short-acting β2-agonist (SABA).