22nd May 2018 11:39
LONDON (Alliance News) - Respiratory-focused pharmaceutical company Circassia Pharma PLC said Monday it plans to submit New Drug Applications in the US for its treatment products Duaklir and Tudorza in the coming weeks following positive end point results for both treatments.
In the phase three trial, which was conducted by testing Duaklir on 1,500 patients suffering chronic obstructive pulmonary disease, both primary endpoints were achieved, with increased forced expiratory volume compared with aclidinium monotherapy and formoterol monotherapy.
Tudorza was used in a phase four ASCENT study to evaluate its long term effect on cardiovascular safety and chronic obstructive pulmonary disease exacerbations.
The study was conducted in 3,600 patients, and both primary endpoints were achieved, with Tudorza reducing the rate of exacerbations with no increase in cardiovascular events in the at-risk population.
"With both the ASCENT and AMPLIFY studies meeting their primary endpoints, the positive data presented at the American Thoracic Society conference are highly supportive for Tudorza and Duaklir. As a result, we look forward to regulatory filings in the coming weeks seeking US approval for Duaklir and an extension to Tudorza's US prescribing information to include the ASCENT data," said Chief Executive Officer Steve Harris.
Shares in Circassia Pharmaceuticals were down 1.5% at 93.80 pence on Tuesday.
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