GlaxoSmithKline (GSK) and Theravance have received marketing authorization from the European Commission (EC) for their jointly-developed asthma and chronic obstructive pulmonary disease (COPD) drug 'Relvar Ellipta'.
Relvar, which is a combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol 'VI ' (FF/VI), is currently licensed across 31 European countries.
The drug is indicated for regular treatment of asthma in adults and adolescents aged at least 12 years who require a combination medicinal product because their symptoms are not adequately managed with inhaled corticosteroids and 'as-needed' inhaled short-acting beta2-agonist.
Two strengths of FF/VI have been approved for asthma 92/22 mcg and 184/22 mcg, given once daily.
FF/VI is also recommended for treatment of symptoms in adults with COPD with a forced expiratory volume in one second lower than 70% predicted normal with a history of exacerbation, despite regular bronchodilator therapy, while the approved strength in COPD is 92/22 mcg once daily.
According to the company, both strengths will be delivered once-daily using Ellipta, a new dry powder inhaler (DPI).
GSK Global Respiratory Franchise SVP and head Darrell Baker said for many years the company has been focused on developing a portfolio of new treatments for patients across the world with asthma and COPD.
"We are delighted that Relvar Ellipta is now licensed, which means that healthcare professionals across Europe will have the option to prescribe an ICS/LABA that offers 24-hour efficacy from a once-daily dose, delivered in our new Ellipta inhaler," Baker said.
As part of a collaboration agreement between the companies signed in 2002, Theravance will now make a milestone payment to GSK of $15m as well as a further $15m for the launch of Relvar Ellipta in Europe.
The European Medicines Agency (EMA) as part of its assessment had reviewed results of ten clinical studies in 7,783 patients with COPD and 16 studies in 9,326 patients with asthma.
