Rns...26 Jul 2013 14:19
TIDMVEC
RNS Number : 2623K
Vectura Group plc
26 July 2013
Ultibro(R) Breezhaler(R) (QVA149), a first in class, once-daily, dual bronchodilator, gains positive CHMP opinion for the treatment of COPD
-- QVA149 (indacaterol/glycopyrronium) is the first once-daily, fixed-dose combination of long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA) bronchodilators to gain positive opinion from the Committee for Medicinal Products for Human Use (CHMP)
-- Pivotal Phase III IGNITE study data showed QVA149 significantly improved lung function and patient-reported outcomes, including breathlessness and rescue medication use, compared to current standard of care(1)
-- QVA149 demonstrated significantly reduced rates of COPD exacerbations and improved health-related quality of life compared to open-label tiotropium 18 mcg and glycopyrronium 50 mcg(2,3)
Chippenham, 26 July 2013 - Vectura Group plc ("Vectura"; LSE: VEC) is pleased to note the information released today by Novartis that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for approval of once-daily Ultibro(R) Breezhaler(R) (indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Ultibro Breezhaler was developed under the name QVA149.
QVA149 is an investigational, fixed-dose combination of two bronchodilators, indacaterol, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium, a long-acting muscarinic antagonist (LAMA).
Dr Chris Blackwell, Chief Executive of Vectura, commented:
"The CHMP's opinion supports QVA149 as a treatment option for COPD and represents a very important step towards the approval of QVA149 in Europe. The positive results returned from the Phase III IGNITE program give us confidence that QVA149 could be the first LAMA/LABA combination product to provide benefit to patients with COPD, a growing, multi-billion dollar market."
QVA149 significantly improved the rate of all exacerbations compared to open-label (OL) tiotropium 18 mcg, glycopyrronium 50 mcg and was comparable to salmeterol/fluticasone (SFC) 50 mcg/500 mcg(3) . The rate of moderate or severe exacerbations was significantly lower compared to glycopyrronium 50 mcg and was numerically lower compared to OL tiotropium 18 mcg(2,3) .
In clinical studies undertaken by Novartis, QVA149 demonstrated an acceptable safety profile with no meaningful differences in the incidence of adverse and serious adverse events between the treatment groups (placebo, indacaterol 150 mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, SFC 50 mcg/500 mcg)(2,4,5) .
The European Commission generally follows the recommendations of the CHMP and normally grants a marketing authorization within three months of