Novartis' Onbrez Breezhaler beats Spiriva in new study of COPD patients; Afinitor reduces SEGAs size

Swiss drug major Novartis (NOVN: VX) had a couple of boosts regarding clinical trials, first with its once-daily Onbrez Breezhaler (indacaterol), which was shown to be superior to tiotropium (Spiriva from US pharma behemoth Pfizer and Germany’s Boehringer Ingelheim) in reducing breathlessness for patients with chronic obstructive pulmonary disorder (COPD), and in addition is as effective as tiotropium in improving patients' lung function and second regarding its Afinitor (everolimus) in the treatment of brain tumors.

This data builds on data presented earlier this year and adds to the growing body of evidence that indacaterol is a highly effective maintenance treatment option in COPD. Novartis has three additional investigational treatments in its COPD portfolio, NVA237, QVA149 and QMF149. The company is also exploring new pathways in the treatment of COPD as part of an innovative, early-stage pipeline, it says. The results were presented at the annual CHEST meeting of the American College of Chest Physicians (ACCP) in Vancouver, Canada.

Onbrez was approved in the European Union in November last year. It has already been launched in 12 markets (and approved in 40) and has generated sales of $16 million in the first nine months of this year, $8 million of which came in the third quarter. However, the drug still awaits a decision in the world’s biggest market, the USA, where it was the subject of a complete response letter a month earlier from the US Food and Drug Administration but Novartis submitted data from additional studies to the agency in September this year.