FDA Approves Yupelri as New Treatment for Adults with COPD
Theravance Biopharma and Mylan announced that the U.S. Food and Drug Administration (FDA) approved their New Drug Application (NDA) for revefenacin (TD-4208) as a maintenance treatment for chronic obstructive pulmonary disease (COPD). The therapy will be marketed as an inhalation solution with the brand name Yupelri.
The companies submitted the NDA in January 2018.
Yupelri is a long-acting muscarinic antagonist (LAMA) developed to be administrated once daily via a nebulizer. It acts as a bronchodilator.
The FDA has authorized pill and liquid versions of LAMAs, but Yupelri is the first approved once-daily LAMA in a mist compatible with common nebulizers.
“This approval, which comes during National COPD Awareness Month, is a testament to the collaborative efforts of the Theravance Biopharma and Mylan teams and their dedication to bringing an important treatment option for adults that suffer from COPD,” Rick E Winningham, chairman and CEO of Theravance Biopharma, said in a press release. “With this approval, COPD patients who require or prefer nebulized therapy can access a once-daily nebulized bronchodilator for the first time.”
The companies expect Yupelri to be available in the U.S. market before the end of 2018.
“Yupelri is a welcome new option for the COPD community, including patients and clinicians,” said Sanjay Sethi, MD, professor and assistant vice president for health sciences at the University at Buffalo. “With its approval, clinicians will be better able to treat a broad range of COPD patients once daily, including those who are not able or choose not to use hand-held bronchodilators.”
The FDA’s decision was based on data from three Phase 3 trials (NCT02512510, NCT02459080, and NCT02518139), which demonstrated the efficacy and safety of Yupelri in comparison to a placebo.
The trials assessed the therapeutic activity of two doses (88 mcg and 175 mcg) of Yupelri inhalation solution, administered once daily in approximately 2,300 patients with moderate to severe COPD. Pooled data from the trials showed that both Yupelri doses could significantly improve patients’ lung function, as determined by clinically meaningful changes in forced expiratory volume in one second (FEV1) compared to a placebo.
In addition, Yupelri was shown to be safe and less aggressive than standard-care therapy Spiriva (tiotropium), developed by Boehringer Ingelheim.
The most adverse effects reported across all treatment groups were cough, inflammation of the nasal cavities and pharynx, upper respiratory tract infection, headache, and back pain.
Yupelri should not be used in acutely deteriorating COPD or to treat acute symptoms.
“The approval of Yupelri represents a key milestone in advancing and expanding our scientific expertise regarding respiratory care,” said Rajiv Malik, president of Mylan. “Yupelri provides COPD patients with access to a nebulized LAMA therapy that offers consistent 24-hour lung function improvement with the convenience of once-daily dosing delivered through any standard jet nebulizer.”
