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Mylan, Theravance's Yupelri approved by FDA for COPD

November 12, 2018 By pharmafile

Mylan and Theravance Biopharma on Friday announced that the FDA approved Yupelri (revefenacin) as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). The companies, which expect to launch the drug by the end of the year, said that the long-acting muscarinic antagonist (LAMA) is the first once-daily nebulised bronchodilator approved for this indication in the US. 

In two Phase III studies, which data were unveiled in 2016, Yupelri was shown to significantly improve trough forced expiratory volume in one second versus placebo after 12 weeks of treatment.  

Mylan president Rajiv Malik noted "Yupelri provides COPD patients with access to a nebulised LAMA therapy that offers consistent 24-hour lung function improvement with the convenience of once-daily dosing delivered through any standard jet nebuliser. 

Commenting on the news, Baird analyst Brian Skorney, who estimates Yupelri may achieve sales exceeding $250 million in 2030, remarked "we think the opportunity for a nebulised LAMA is relatively limited by the treatment paradigm in COPD, where combination therapy is the mainstay and there is wide availability of numerous inhalers containing two-three mechanisms in one." 

Mylan and Theravance's filing seeking approval of Yupelri was accepted by the FDA in January. The drugmakers jointly developed the therapy under the terms of a 2015 partnership. 

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