Novartis has been presenting impressive data on its new chronic obstructive pulmonary disease drugs, most notably on its combination treatment QVA149.
At the European Respiratory Society meeting in Vienna, the Swiss major gave information on three new studies of QVA149, which combines its own Onbrez Breezhaler (indacaterol), a long-acting beta 2-agonist (LABA) and Seebri Breezhaler (glycopyrronium), its investigational long-acting muscarinic antagonist (LAMA). They showed that the combo, developed with the UK’s Vectura and Japan’s Sosei, showed a superior effect on lung function and patient-reported outcomes versus comparators.
Specifically in one of the studies called Shine, part of the Ignite Phase III programme for the drug, met its primary endpoint by demonstrating that once-daily QVA149 improved lung function as measured by trough FEV compared to once-daily indacaterol and glycopyrronium. It was also more effective at improving lung function and without additional side effects compared to Boehringer Ingelheim’s COPD blockbuster Spriva (tiotropium) and placebo.
In one of the other studies.the drug also beat GlaxoSmithKline’s Seretide/Advair (salmeterol/fluticasone), which is the most prescribed COPD drug. The latter is an inhaled corticosteroid (ICS) combined with a LABA. However, the vast majority of respiratory experts PharmaTimes World News spoke to at ERS said they believe a LABA/LAMA is more effective and the data coming from QVA149 seems to confirm that.
David Price, professor of primary care respiratory medicine at the University of Aberdeen, told PT that doctors have had problems distinguishing between COPD and asthma and many have plumped for an ICS/LABA like Advair, which is approved for COPD but is predominantly prescribed for asthma.
Prof Price said he was surprised by the level of benefit shown by QVA149 and analysts were impressed as well. Deutsche Bank issued a research note saying that “physicians remain enthusiastic about the LABA/LAMA class given potential to improve compliance and lung function and reduce needless exposure to corticosteroids”. Last month Novartis said it will file QVA149 in Europe and Japan in the fourth quarter.
Boehringer LAMA/LABA drug
Also at ERS, Boehringer published positive Phase II data on its investigational LABA, olodaterol, combined with the LAMA Spiriva. Presenting the data in Vienna, Rene Aalbers of the Martini Hospital in Groningen, the Netherlands, described the data as “amazing”, adding that olodaterol is an ideal partner to Spiriva due to its similar long-lasting effect at a low dose.
However the clinical programme for the Spiriva/olodaterol combo will not be completed for some time, and some observers believe QVA149 will have valuable time on the market ahead of the competition.
