FDA Drug Approvals: Primary Care — Year in Review 2018

Mary L Windle, PharmD


January 15, 2019

New Pulmonary Drugs

Yupelri (revefenacin)

Revefenacin is a nebulized, once-daily, long-acting muscarinic antagonist (LAMA) for maintenance treatment of chronic obstructive pulmonary disease (COPD). It blocks the action of acetylcholine at muscarinic receptors (M1 to M5) in the bronchial airways, leading to bronchodilation.

Revefenacin 175 mcg/day significantly improved trough forced expiratory volume in 1 second (FEV1) and decreased albuterol rescue doses compared with placebo (P <.001) over a 28-day period. (Respir Res. 2017 Nov 2;18(1):182) Results from a 52-week safety and tolerability study were presented at the American Thoracic Society 2018 International Conference.

Symdeko (tezacaftor/ivacaftor)

Tezacaftor/ivacaftor is indicated for patients aged 12 years or older with cystic fibrosis who are homozygous for the F508del mutation or who have at least one mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. It is available as a copackaged fixed-dose combination tablet of tezacaftor 100 mg and ivacaftor 150 mg plus a separate ivacaftor 150-mg tablet.

Approval was based on the EVOLVE and EXPAND phase 3 clinical trials. Results showed measured improvements across multiple disease measures, including lung function and pulmonary exacerbations, compared with ivacaftor monotherapy. (N Engl J Med. 2017 Nov 23;377(21):2013-2023); (N Engl J Med. 2017 Nov 23;377(21):2024-2035)


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