Novartis to present data from three clinical trials

Novartis announced that a wealth of new data from its respiratory portfolio will be presented at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany. In total, 44 abstracts (including four late-breakers) will be presented by Novartis, representing more than any other company at the congress.

"Novartis is committed to making a difference to the lives of millions of people worldwide living with debilitating conditions, such as COPD and severe asthma," said Vasant Narasimhan, global head of development, Novartis Pharmaceuticals. "We hear from patients how their lives have improved because of our respiratory medicines, and this motivates us to continue to advance respiratory treatments in our portfolio."

Positive new results from the phase III head-to-head LANTERN study showed the superiority of once-daily, dual bronchodilator, Ultibro Breezhaler (indacaterol/glycopyrronium bromide) in improving lung function compared to twice-daily Seretide Accuhaler (salmeterol/fluticasone combination: LABA/ICS), in patients with moderate-to-severe COPD.

GSK, Theravance submit sNDA to US FDA - furoate/vilanterol

GlaxoSmithKline plc and Theravance, announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (US FDA) for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of Breo Ellipta.

The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.

Today’s filing is based upon data generated from the comprehensive clinical development programme for FF/VI in asthma. The clinical development programme comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in December 2013.

Asthma is a chronic lung disease that inflames and narrows the airways, causing recurring periods of wheezing, chest tightness, shortness of breath and coughing which often occurs at night or early in the morning.