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ZUG, Switzerland, Oct. 25, 2022 (GLOBE NEWSWIRE) — Covis Pharma Group (“Covis”), a worldwide specialty pharmaceutical firm that markets therapeutic options for sufferers with life-threatening circumstances and continual sicknesses, right this moment introduced constructive topline outcomes from the AVANT section 3 scientific trial for Duaklir® (aclidinium bromide 400µg /formoterol 12µg twice-daily) and Eklira® (aclidinium bromide 400µg twice-daily) – generally known as Tudorza® in the U.S. This 24-week research achieved statistically important and clinically necessary outcomes for all key endpoint measures of efficacy in grownup sufferers with reasonable to extreme secure continual obstructive pulmonary illness (COPD).
The main efficacy endpoints of the research had been a change in baseline of FEV1 of the 1-hour morning post-dose FEV1 for aclidinium/formoterol versus aclidinium, and the change from baseline of the morning pre-dose FEV1 of aclidinium/formoterol versus formoterol and aclidinium versus placebo.
A complete of 1,060 sufferers with reasonable to extreme secure COPD had been included in the trial. Seventy p.c of the contributors had been from China, with different contributors coming from Taiwan, India, Vietnam, and the Philippines. Patients had been randomized equally to placebo, aclidinium bromide monotherapy (Eklira), aclidinium bromide/formoterol fumarate mixture remedy (Duaklir), and monotherapy formoterol for a 24-week interval. There had been no new security considerations raised in the research and the findings had been in step with the identified security profiles of aclidinium bromide and aclidinium bromide/formoterol. The security and tolerability of each aclidinium and aclidinium/formoterol had been corresponding to placebo.
AstraZeneca, who carried out the research, transferred its international rights for Duaklir and Eklira to Covis in November 2021.
“The positive results from this phase 3 clinical trial demonstrate a promising step to expand our global respiratory portfolio into important new regions,” mentioned Raghav Chari, PhD, Chief Innovation Officer at Covis Pharma. “These data further strengthen our confidence in these two medicines and support our intent to pursue the regulatory path to make these treatment options available to a broader population of COPD patients.”
Detailed outcomes of the research are deliberate for future publication. A full evaluation of the AVANT knowledge is ongoing with full outcomes to be supplied, or submitted with the AVANT NDA, to the China Food and Drug Administration (CFDA).
About the Medicines
Eklira (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the upkeep remedy of COPD. Eklira is a long-acting muscarinic antagonist (LAMA), which is marketed in the US as Tudorza and in some international locations as Bretaris®. Duaklir is a mixture remedy that comprises each a LAMA and a long-acting beta2-agonist (LABA). It is marketed in some international locations as Brimica®. Both medicines are offered as a dry powder for oral inhalation and are delivered by way of a breath-actuated multi-dose dry powder inhaler, Genuair® (Pressair® in the US).
About Covis Pharma
Covis Pharma, based in 2011 and headquartered in Luxembourg, is a worldwide specialty pharmaceutical firm that markets therapeutic options for sufferers with life-threatening circumstances and continual sicknesses. Additional info on the Company is out there at www.covispharma.com.
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