FDA approves new dual combination bronchodilator Utibron Neohaler and stand-alone monotherapy Seebri Neohaler for patients with COPD
Utibron Neohaler (formerly QVA149;indacaterol/glycopyrrolate) demonstrated superior and sustained improvements in lung function compared to either of its single bronchodilator components as well as placebo, and improved lung function compared to placebo at 5 minutes after the first dose and throughout the dosing interval.
Vectura Group confirms the information released by its alliance partner Novartis announcing that the FDA has approved the dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) and the stand-alone monotherapy Seebri Neohaler (glycopyrrolate), which is one component of Utibron Neohaler. Utibron Neohaler and Seebri Neohaler are approved for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The approval of Utibron Neohaler and Seebri Neohaler triggers a $22.5m milestone payment from Novartis to Vectura.
James Ward-Lilley, Chief Executive of Vectura commented: "The launches of Novartis' Ultibro Breezhaler and Seebri Breezhler ex-US have demonstrated the effectiveness of these products and the need for new treatment options for patients with COPD in the US. For the first 9M 2015, Novartis reported $297m in sales for these products which represented 174% growth. Once launched, the products will bring a new royalty stream for Vectura and we look forward to confirmation from our partner in due course on their plans for the commercialisation of these products."
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