According to Covis Pharma, the Phase 3 AVANT trial of Duaklir aclidinium bromide / formoterol and Eklira (Tudorza) aclidinium bromide DPIs demonstrated statistically significant change in FEV1 from baseline one hour post dose for Duaklir vs Eklira alone and vs formoterol alone, as well as for Eklira vs placebo. Covis acquired global rights to Duaklir and Eklira from AstraZeneca in November 2021.
The trial enrolled 1,060 patients in China, Taiwan, India, Vietnam and the Philippines who had moderate-to-severe COPD. Approximately 70% of the subjects were Chinese, and the company said that it intends to submit complete results from the AVANT study to the CFDA to support an NDA.
The Eklira / Tudorza aclidinium DPI has been approved in both the US and Europe since July 2012. Duaklir has been approved in Europe since November 2014 and in the US since March 2019.
Covis Pharma Chief Innovation Officer Raghav Chari commented, “The positive results from this Phase 3 clinical trial demonstrate a promising step to expand our global respiratory portfolio into important new regions. 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.”
Read the Covis Pharma press release.
