Boehringer’s HandiHaler, used to administer Spiriva
Novartis and Boehringer Ingelheim have both announced positive late-stage data on fixed-dose combination drugs to treat chronic obstructive pulmonary disease (COPD).
Boehringer already has a leading position in the COPD market with its long-acting muscarinic antagonist (LAMA) Spiriva (tiotropium), and has now reported the first phase III data on a follow-up that combines tiotropium with the company’s long-acting beta agonist Striverdi (olodaterol).
The fixed-dose combination – given once-daily – was shown to be more effective in improving lung function in COPD patients than placebo or either of the two drugs given as a monotherapy over the six-week VIVACITO study.
Klaus Rabe of the University of Kiel in Germany, the lead investigator in the trial, said the degree of benefit with the fixed-dose combination was remarkable, with a 200ml improvement in forced expiratory volume (FEV1) a significant advance.
“A few years ago we would simply not have thought this level of improvement would be possible,” he said.
Boehringer is currently conducting two 52-week trials of the tiotropium/olodaterol combination, which should generate results later this year and should support a marketing application shortly thereafter.
Meanwhile, Novartis has announced positive results from a late-stage trial comparing its already-marketed LAMA/LABA combination Ultibro (glycopyrronium and indacaterol) to Spiriva and formoterol given separately.
The QUANTIFY trial showed that Ultibro was as effective as the comparator combination in improving health-related quality of life measures, and was more effective at improving lung function. Spiriva was given as a once-daily dose while formoterol was administered twice-a-day in the trial.
Data from both studies were presented this week at the American Thoracic Society (ATS) conference in San Diego.
LAMA/LABA combinations provide the convenience of delivering the two major bronchodilator classes that are recommended as first-line maintenance options in treatment guidelines and so are expected to make significant headway in the asthma and COPD market, which is predicted to swell from $34bn in 2012 to more than $41bn by 2017, according to market research firm Visiongain.
The sector is currently dominated by Spiriva and GlaxoSmithKline’s beta agonist/corticosteroid combination Advair/Seretide (salmeterol and fluticasone), which together captured two thirds of the market in 2012.
Ultibro (formerly QVA149) was the first LAMA/LABA to be approved for marketing in the EU, while rival product Anoro (umeclidinium bromide and vilanterol) from GlaxoSmithKline was the first drug in the category to reach the US market.