GlaxoSmithKline and biopharmaceutical company Theravance have announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing approval for fluticasone furoate/vilanterol (FF/VI) under the proposed brand name RELVAR ELLIPTA for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The EMA's positive opinion recommending marketing authorization for RELVAR ELLIPTA is based on the results from 11 clinical studies in 7,851 patients with COPD and 16 studies in 9,326 patients with asthma.
RELVAR is a combination of fluticasone furoate (FF), an inhaled corticosteroid, and vilanterol (VI), a long-acting beta2-agonist.
For asthma, two strengths (92/22 mcg and 184/22 mcg) of FF/VI per day are proposed and for COPD one strength (92/22 mcg) of FF/VI per day is proposed, and these strengths will be administered by using a new dry powder inhaler ELLIPTA.
The European Commission is expected to issue a final decision regarding marketing authorization for RELVAR ELLIPTA in the fourth quarter of 2013.
A regulatory filing has been submitted in Japan in September 2012 for FF/VI under the trade name Relvar Ellipta and is currently under review for asthma. FF/VI is not approved or licensed in the European Union or anywhere outside the US and Canada.
