Verona Pharma submits FDA New Drug Application for COPD treatment
UK-based Verona Pharma has announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its chronic obstructive pulmonary disease (COPD) maintenance drug, ensifentrine.
Ensifentrine is a selective dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4) combining bronchodilator and non-steroidal anti-inflammatory activities in one molecule. The high dual sensitivity of PDE3 and PDE4 over other enzymes and receptors minimises off-target effects, while direct delivery to the lungs via inhalation maximises pulmonary exposure while lessening systemic distribution.
More than 2,200 patients have been dosed with the drug through phase 1-3 ENHANCE clinical trials, with ensifentrine being well-tolerated throughout. The drug met its primary endpoints in ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. It also reduced the rare and risk of COPD exacerbations in analysis.
David Zaccardelli PharmD, president and CEO of Verona Pharma, stated: “Millions of symptomatic COPD patients in the US are in urgent need of new treatment options. The NDA submission for ensifentrine is a significant milestone towards our goal of bringing this potential first-in-class therapy to COPD patients and we look forward to working with the FDA during their review.”
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