GSK COPD combination better than AZ rival - trial

GlaxoSmithKline has said its combination therapy for chronic obstructive pulmonary disease (COPD) has met its goal in a late-stage study by producing better results than an AstraZeneca rival.

GSK said it plans to file its once daily closed triple combination therapy of fluticasone furoate, umeclidinium and vilanterol by the end of the year in COPD.

The combination is an inhaled corticosteroid, long acting muscarinic antagonist and a long-acting beta agonist.

It met its co-primary endpoints in the phase 3 FULFIL study, showing statistically significant improvements compared with AZ's Symbicort Turbohaler (budesonide+formoterol) in lung function measured by lung capacity and a respiratory questionnaire.

The safety profile of the closed triple combination at both 24 weeks and the 52-week extension was consistent with the known profile of the individual medicines and their combinations. At 24 and 52 weeks, the most common adverse events across both treatment arms were nasopharyngitis, headache and COPD worsening.

The announcement comes months after GSK’s struggling respiratory division suffered a setback, when the large-scale SUMMIT trial failed to show its Relvar Ellipta (fluticasone furoate+vilanterol) improved survival in COPD compared to placebo.

GSK hoped the new use for Relvar Ellipta would boost sales, according to some estimates by up to $1 billion.

This would help offset a decline in revenues from older drug Seretide/Advair (fluticasone propionate+salmeterol), which faces pricing pressure in the US and competition from rival therapies.

Sales of Seretide were down a reported 16% to £753 million in the first quarter of 2016, compared with the corresponding period last year. Relvar generated sales of £111 million in Q1 but has not kept pace with the decline in sales of Seretide, which peaked at more than £5 billion around six years ago.

GSK is planning US and EU filings by the end of the year, and detailed results from FULFIL will be presented at a forthcoming scientific meeting.