1日１回LAMA レベフェナシン 米国FDA認可

1日１回LAMA　レベフェナシン　米国FDA認可:



Theravance Biopharma and Mylan Receive FDA Approval for YUPELRI™ (revefenacin) in Adults with Chronic Obstructive Pulmonary Disease

http://newsroom.mylan.com/2018-11-09-Theravance-Biopharma-and-Mylan-Receive-FDA-Approval-for-YUPELRI-TM-revefenacin-in-Adults-with-Chronic-Obstructive-Pulmonary-Disease



JAMA誌解説

https://jamanetwork.com/journals/jama/fullarticle/2718777

２つの第３相試験、1225名の中等・重症COPDを revefenacin 88μg、175μg vs プラシーボランダム化、１２週後、FEV1の介入薬剤統計学的臨床的改善。副作用頻度の多いのは咳嗽、鼻咽頭炎、上気道感染、頭痛

Efficacy and safety of revefenacin (REV), a long-acting muscarinic antagonist for nebulization: results of replicate randomized, double-blind, placebo-controlled, parallel-group phase 3 trials in participants with moderate to very severe COPD

Gary Ferguson, Krishna K. Pudi, Gregory Feldmann, Srikanth Pendyala, Chris N. Barnes, Edmund J. Moran, Glenn Crater, Brett Haumann

European Respiratory Journal 2017 50: PA1812;

DOI: 10.1183/1393003.congress-2017.PA1812

52週間安全性トライアル 1055名 revefenacin 88μg、175μg vs プラシーボランダム化、175μg群がプラシーボ・ 88μg群に比べCOPD急性増悪減少。副事象は12週間トライアルと同様口腔内乾燥頻度はrevefenacin群で少ない

Revefenacin, a Once-Daily, Long-Acting Muscarinic Antagonist for Nebulized Therapy of Chronic Obstructive Pulmonary Disease (COPD): Results of a 52-Week Safety and Tolerability Phase 3 Trial in Participants with Moderate to Very Severe COPD

E.M. Kerwin,  et al.

ATS Conferences　ATS 2018　　B102. CLINICAL TRIALS AND STUDIES IN COPD

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日本で治験されてない？

ネブライザーのみ可能な症例って結構多いと思うのだけど・・・マーケット形成できないのだろうか？