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【转自药渡网】Teva 报告了乐观哮喘临床3期评估结果
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Teva 对临床3期评估了对于哮喘患者干粉吸入器 (MDPIs)吸入Fluticasone Propionate /Salmeterol和多剂量Fluticasone Propionate 的实验效果，实验数据很好。研究表明通过使用干粉吸入器 (MDPI)，低剂量与安慰剂相比具有更大的效能，结果展示 Teva 扩大呼吸的研发能力和支持其核心，呼吸驱动MDPI平台的发展。最初的结果显示fluticasone propionate/salmeterol MDPI的不良事件可以和fluticasone propionate治疗和安慰剂媲美。 相关阅读： Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma Studies demonstrate greater efficacy with lower doses delivered via multidose dry-powder inhaler (MDPI) compared to placebo Results showcase Teva’s expanding respiratory R&D capabilities and support advancement of core, breath-actuated MDPI platform Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced positive top-line results from three Phase III clinical studies designed to evaluate the efficacy and safety of fluticasone propionate/salmeterol, a combination inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) delivered via a multidose dry powder inhaler (MDPI) and fluticasone propionate, an ICS monotherapy delivered via a MDPI in adolescent and adult patients with asthma. Top-line data showed that the studies met their primary endpoints. Importantly, the studies also showed similar overall safety profiles as compared to therapies in the corresponding drug classes. “These data support Teva’s commitment to further optimize the treatment of respiratory disease through the development of devices and therapies that help address the needs of patients and physicians,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “With this dual development program we have demonstrated clinically significant levels of effectiveness, by delivering combination and monotherapy at lower doses utilizing our core, breath-actuated, MDPI platform.” Fluticasone propionate/salmeterol MDPI demonstrated, in the double-blind studies, clinically relevant and greater benefit at all doses (50/12.5, 100/12.5, and 200/12.5 mcg BID nominal delivered doses) versus placebo and versus respective monotherapy (fluticasone propionate) in the improvement of lung function as measured by the change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the 12-week trial period and standardized baseline-adjusted area under the effect curve FEV1 from time 0 to 12 hours post dose at Week 12. This initial set of results shows the adverse event profile of fluticasone propionate/salmeterol MDPI was comparable to fluticasone propionate monotherapy and placebo. Fluticasone propionate MDPI also demonstrated clinically relevant and greater benefit at all doses (50, 100, and 200 mcg BID nominal delivered doses) versus placebo in the improvement of lung function, in the double-blind studies. The initial set of results shows the adverse event profile of fluticasone propionate MDPI was comparable to placebo. The majority of adverse events were mild to moderate in severity. There were no drug-related deaths across any of the trials. Further analyses of additional efficacy and safety data are ongoing. Full results will be submitted for presentation at future scientific meetings and for publication in peer reviewed journals. “We have made significant progress in furthering our respiratory pipeline with a focus on a complete asthma management system utilizing our breath-actuated MDPI platform,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We have successfully developed and launched products that utilize our breath-actuated MDPI platform in select markets around the world. These data support the broadening of our portfolio in using this technology to develop and deliver additional respiratory therapeutic options.” Regulatory submissions for both fluticasone propionate/salmeterol MDPI and fluticasone propionate MDPI in the U.S. are planned for 2016. |
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