Novartis seeks FDA approval for lung drugs

pharmafile | January 8, 2015 | News story | Sales and Marketing |  Advair, FDA, GSK, NVA237, Novartis, QVA149, Seretide, asthma, lung copd 

Novartis has submitted two new lung treatments for FDA approval after ‘robust’ Phase III trial results.

If approved, QVA149 and NVA237, which are designed to improve breathing in chronic obstructive pulmonary disease (COPD) patients, would be available in the US for the first time after being available in Europe and other regions for several years.

“There is an urgent need for new treatment options in COPD because many patients remain symptomatic despite medical therapy,” Novartis says in a statement.

The Phase III FLIGHT trials for QVA149 (indacaterol/glycopyrronium bromide) met their primary objectives with the drug demonstrating ‘statistically significant and clinically meaningful’ improvements in lung function after 12 weeks.

The results also showed an improvement in overall health status and recuse medicines usage compared to placebo. Meanwhile, its GEM 1 and 2 studies showed similar results for NVA237 (glycopyrronium bromide) in patients with moderate to severe COPD.

The drugs are both marketed with Novartis’ Breezhaler inhalation device outside US. NVA237 is branded as Seebri Breezhaler and QVA149 as Ultibro Breezhaler – although the FDA submission is for a twice-daily dosage of QVA149 rather than the once-daily variation used elsewhere.

Novartis previously presented results at the Munich ERS conference in November last year, showing that Ultibro was superior in reducing flare-ups compared to GlaxoSmithKline’s Seretide Accuhaler (fluticasone/salmeterol), the biggest-selling COPD drug.

The LANTERN study found that the once-daily Ultibro was better in reducing exacerbations and improving lung function compared to the twice-daily Seretide.

There are plenty of other competitors in the market however, including AstraZeneca’s Symbicort (budesonide/formoterol) and Spiriva (tiotropium bromide) from Boehringer Ingelheim and Pfizer. GlaxoSmithKline also markets Advair (salmeterol and fluticasone), but the drug’s patents expired in Europe in 2013, dealing a heavy blow to the firm’s sales.

COPD is a progressive and often fatal disease that makes breathing difficult. The World Health Organization estimates that 220 million people worldwide suffer from it, and it affects over three million people in the UK every year. Chronic bronchitis and emphysema are associated with COPD diagnosis.

George Underwood