Ensifentrine: First Approval

World Health Organisation. Chronic obstructive pulmonary disease (COPD) fact sheet. 2023. https://www.who.int/. Accessed 16 Jul 2024.

Terry PD, Dhand R. The 2023 GOLD report: updated guidelines for inhaled pharmacological therapy in patients with stable COPD. Pulm Ther. 2023;9(3):345–57.

Article  PubMed  PubMed Central  Google Scholar 

Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phosphodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE trials). Am J Respir Crit Care Med. 2023;208(4):406–16.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cazzola M, Hanania NA, Page CP, et al. Novel anti-inflammatory approaches to COPD. Int J COPD. 2023;18:1333–52.

Article  CAS  Google Scholar 

Calzetta L, Page CP, Spina D, et al. Effect of the mixed phosphodiesterase 3/4 inhibitor RPL554 on human isolated bronchial smooth muscle tone. J Pharmacol Exp Ther. 2013;346(3):414–23.

Article  CAS  PubMed  Google Scholar 

Verona Pharma plc. Ensifentrine: US prescribing information. 2024. https://ohtuvayre.com/. Accessed 3 Jul 2024

Abbott-Banner KH, Page CP. Dual PDE3/4 and PDE4 inhibitors: novel treatments for COPD and other inflammatory airway diseases. Basic Clin Pharmacol Toxicol. 2014;114(5):365–76.

Article  CAS  PubMed  Google Scholar 

Verona Pharma plc. Verona Pharma announces US FDA approval of Ohtuvayre™ (ensifentrine) [media release]. 26 Jun 2024. https://www.veronapharma.com/.

Ligand Pharmaceuticals Inc. Ligand partner Verona Pharma announces FDA approval of OhtuvayreTM (ensifentrine), first inhaled novel mechanism for maintenance treatment of COPD in more than 20 years [media release]. 27 Jun 2024. https://www.ligand.com/.

Verona Pharma plc. Form 10-K. 2024. https://www.veronapharma.com/. Accessed 12 Jul 2024.

Verona Pharma plc. Verona Pharma reports positive phase 2 results with pMDI formulation of ensifentrine in COPD [media release]. 2 Feb 2021. https://www.veronapharma.com/.

Verona Pharma plc. Verona Pharma reports positive phase 2 results with dry powder inhaler formulation of ensifentrine in COPD [media release]. 5 Aug 2019. https://www.veronapharma.com/.

Nuance Pharma. Nuance Pharma announces clearance of IND application for ensifentrine pivotal clinical trials for COPD in China [media release]. 18 Aug 2022. https://www.nuancepharma.com/.

Ligand Pharmaceuticals Inc. Ligand announces the close of its acquisition of Vernalis [media release]. 10 Oct 2018. https://www.ligand.com/.

Venkatasamy R, Spina D. Novel relaxant effects of RPL554 on guinea pig tracheal smooth muscle contractility. Br J Pharmacol. 2016;173(15):2335–51.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Calzetta L, Cazzola M, Page CP, et al. Pharmacological characterization of the interaction between the dual phosphodiesterase (PDE) 3/4 inhibitor RPL554 and glycopyrronium on human isolated bronchi and small airways. Pulm Pharmacol Ther. 2015;32:15–23.

Article  CAS  PubMed  Google Scholar 

Franciosi LG, Diamant Z, Banner KH, et al. Efficacy and safety of RPL554, a dual PDE3 and PDE4 inhibitor, in healthy volunteers and in patients with asthma or chronic obstructive pulmonary disease: findings from four clinical trials. Lancet Respir Med. 2013;1(9):714–27.

Article  CAS  PubMed  Google Scholar 

Bjermer L, Abbott-Banner K, Newman K. Efficacy and safety of a first-in-class inhaled PDE3/4 inhibitor (ensifentrine) vs salbutamol in asthma. Pulm Pharmacol Ther. 2019;58:1–7.

Article  Google Scholar 

Singh D, Abbott-Banner K, Bengtsson T, et al. The short-term bronchodilator effects of the dual phosphodiesterase 3 and 4 inhibitor RPL554 in COPD. Eur Respir J. 2018;52:1801074.

Article  PubMed  PubMed Central  Google Scholar 

Turner MJ, Matthes E, Billet A, et al. The dual phosphodiesterase 3 and 4 inhibitor RPL554 stimulates CFTR and ciliary beating in primary cultures of bronchial epithelia. Am J Physiol Lung Cell Mol Physiol. 2016;310(1):L59-70.

Article  PubMed  Google Scholar 

Turner MJ, Luo Y, Thomas DY, et al. The dual phosphodiesterase 3/4 inhibitor RPL554 stimulates rare class III and IV CFTR mutants. Am J Physiol Lung Cell Mol Physiol. 2020;318(5):L908–20.

Article  CAS  PubMed  Google Scholar 

Rickard K, Darpo B, Xue H, et al. The dual phosphodiesterase (PDE) 3 and 4 inhibitor ensifentrine does not prolong QT interval in healthy volunteers [abstract no. A5605]. Am J Respir Crit Care Med. 2022;205.

Rheault T, Kankam M, Ayrton J, et al. The effect of fluconazole on the pharmacokinetics of ensifentrine in healthy individuals [abstract no. PA2137]. Eur Respir J. 2021;58(Suppl 65).

Eneje OJ, Mauerer B, Newman K, et al. A single dose of a novel nebilised PDE3/4 inhibitor RPL554 increased FEV1 in patients with cystic fibrosis and demonstrated a reproducible pharmacokinetic profile [abstract no. 215]. Pediatr Pulmonol. 2018;53(S2):228.

Ferguson GT, Kerwin EM, Rheault T, et al. A dose-ranging study of the novel inhaled dual PDE 3 and 4 inhibitor ensifentrine in patients with COPD receiving maintenance tiotropium therapy. Int J Chron Obstruct Pulmon Dis. 2021;16:1137–48.

Article  PubMed  PubMed Central  Google Scholar 

Singh D, Martinez FJ, Watz H, et al. A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD. Respir Res. 2020;21(1):47.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Siler TM, Fogarty CM, Rheault T, et al. Pooled safety results over 24 weeks from the ENHANCE program with ensifentrine, a novel dual phosphodiesterase (PDE) 3 and 4 inhibitor [abstract]. Chest. 2023;164(4 Suppl):A4981–3.

Article  Google Scholar 

留言 (0)

沒有登入
gif