QVA149 ILLUMINATE Phase III COPD study meets primary endpoint and clarification of anticipated timing of US filings for NVA237 and QVA149
Superior lung function with once-daily QVA149 compared with twice-daily Seretide®1
Study is part of IGNITE Phase III clinical trial program intended to form the basis of regulatory filings in COPD
US filings for NVA237 and QVA149 expected in 2014
Tokyo, Japan – 24 April 2012: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the information released today by Novartis that a fourth study in the IGNITE programme, has met its primary endpoint. All four QVA149 Phase III studies have now met their primary endpoints, including the latest, ILLUMINATE, a head-to-head study against Seretide®, demonstrating its strong potential to address the unmet needs of patients with chronic obstructive pulmonary disease (COPD).
The ILLUMINATE study in more than 500 patients demonstrated that superior lung function (measured by FEV1 AUC0-12h with a p value <0.001) was achieved with once-daily QVA149 compared with twice-daily Seretide® (fluticasone 500mcg / salmeterol 50mcg) in patients with moderate to severe COPD.
After discussions with the Food and Drug Administration (FDA), Novartis also confirmed today that they have agreed on the Phase III trial design for QVA149 as well as NVA237 for the US and that they expect the filing for NVA237 to take place at the beginning of 2014 with QVA149 following at the end of 2014. CEO of Sosei, Shinichi Tamura commented: “The ILLLUMINATE study will be an important part of the regulatory submission for QVA149 and achieving superior lung function given once daily versus twice-daily Seretide® gives us more confidence in the potential of QVA149 in the treatment of patients with COPD. We now have clarity on US filing timelines for both NVA237 and QVA149 and we look forward to a decision from the EU regulators on NVA237 in the near future”
Data from three other studies in the IGNITE program were announced recently. SHINE, with an enrolment of more than 2,100 patients, demonstrated the superiority in trough FEV1 (p<0.001) of once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD. In addition, QVA149 showed superiority in trough FEV1 (p<0.001) compared to placebo and open-label tiotropium (18 mcg). The results of BRIGHT showed that patients experienced significantly better exercise endurance versus placebo (p=0.006). ENLIGHTEN demonstrated that QVA149 was well tolerated with a safety and tolerability profile similar to placebo.
The studies, ILLUMINATE, SHINE, BRIGHT and ENLIGHTEN, are part of the IGNITE clinical trial program intended to form the basis for filing QVA149 in COPD in the EU, Japan and other countries. IGNITE is one of the largest international patient registration programs in COPD, comprising 10 studies in total, and including more than 5,700 patients across 42 countries. These studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, dyspnoea and quality of life. Three more QVA149 Phase III studies (SPARK, BLAZE and ARISE) are expected to complete in 2012.
QVA149 (indacaterol 110 mcg / glycopyrronium bromide 50 mcg) is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA)indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237). Data from the IGNITE clinical trial program, examining QVA149 in a number of settings, will be submitted for presentation to a major medical congress later this year.