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Fly News Breaks for December 16, 2019
NVS
Dec 16, 2019 | 05:28 EDT
Novartis announced topline results from its pivotal global Phase III LUSTER-11and LUSTER-22studies exploring the efficacy and safety of the investigational oral, once-daily, DP2receptor antagonist fevipiprant. The pooled analyses of the LUSTER trials did not meet the clinically relevant threshold for reduction in rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses. The studies included patients who had inadequately controlled moderate-to-severe asthma despite receiving inhaled mid-to-high dose corticosteroids and at least one additional controller. The totality of these results do not support further development of fevipiprant in asthma, Novartis said in a statement. "While the results of the LUSTER studies with fevipiprant are disappointing, they meaningfully contribute to our understanding of the DP2pathway in asthma. We are incredibly grateful to all the patients, their families and the investigators who participated in the studies and contributed greatly to this research," said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis.