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Teva Pharmaceutical Industries: Teva Reports Positive Top-Line Results From Phase Iii Trials Evaluating Fluticasone

The following excerpt is from the company's SEC filing.

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 Tevas expanding respiratory R&D capabilities and support advancement of core,

breath-actuated MDPI platform

JERUSALEM, November 19, 2015

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 Tevas 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 (FEV

) at the 12-week trial period and standardized baseline-adjusted area under the effect curve FEV

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.

About The Studies

Study FSS-AS-301 was a Phase III, 12-week, global, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of fluticasone propionate multidose dry powder inhaler (MDPI) compared with fluticasone...


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