Dec 16, 2019: Novartis announced topline results from its pivotal global Phase III LUSTER-1and LUSTER-2Â studies examing the efficacy and safety of the investigational oral, once-daily, DP2Â receptor antagonist fevipiprant (QAW039).
The pooled analyses of the LUSTER trials did not meet the clinically relevant entrance for reduction in the rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of  doses (150mg / 450 mg).
The studies included patients who had incorrectly controlled moderate-to-severe asthma (GINA Steps 4 and 5) despite receiving inhaled mid-to-high dose corticosteroids (ICS) and at least one additional controller. The entirety of these results do not support further development of fevipiprant in asthma. Fevipiprant, in general well tolerated, with treatment-emergent adverse events normally balanced across groups and comparable to placebo.
Company continues to invest into respiratory medicines with in-market products Xolair® (severe allergic asthma [SAA] and chronic spontaneous urticaria [CSU]), Ultibro® Breezhaler® (COPD), Phase III investigational products QVM149 (moderate-to-severe asthma), and QMF149 (moderate-to-severe asthma), as well as active research programs covering asthma, COPD and other areas of the high unmet need, such as idiopathic pulmonary fibrosis and sarcoidosis. https://www.novartis.com/news/media-releases/novartis-provides-update-luster-phase-iii-studies-patients-uncontrolled-gina-45-asthma
