Mylan, Theravance win FDA approval for COPD drug
- Theravance Biopharma and Mylan on Friday picked up approval for Yupelri for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The thumbs up came a few days ahead of the inhaled therapy's Nov. 13 Prescription Drug User Fee Act date
- According to the companies, Yupelri is the only once-daily, nebulized bronchodilator approved for the treatment of COPD in the U.S. It should hit the market by the end of 2018.
- The American Lung Association says more than 11 million people across the U.S. suffer from COPD. Many patients with the disorder go undiagnosed. Mylan and Theravance noted in a Nov. 9 statement that COPD is the third leading cause of death and the fourth leading cause of hospital re-admissions in the states.
Theravance and Mylan won't have much time to celebrate their drug approval, as they now face the daunting task of launching Yupelri (revefenacin) into a market dominated by several heavyweight brands.
Approved inhaler-based drugs for COPD include AstraZeneca's Symbicort (budesonide/formoterol fumarate) and GlaxoSmithKline's Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol). Like Yupelri, both Symbicort and Trelegy Ellipta contain a long-acting muscarinic antagonist (LAMA).
Sunovion, recently won approval of a twice-daily nebulized LAMA called Lonhala Magnair (glycopyrrolate).
Generics to existing drugs also offer a lower-cost option that could be attractive to patients.
Yupelri's has advantages over the competition, however, according to Sanjay Sethi, assistant vice president for health sciences at the University of Buffalo's Jacobs Scool of Medicine and Biomedical Sciences.
"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 handheld bronchodilators," Sethi said in the Nov. 9 statement from Mylan and Theravance.
Sethi isn't alone in his optimism. Leerink analyst Ami Fadia expects strong uptake of nebulized LAMAs.
"We believe that a large proportion of the current nebulized LABA population will either incorporate or switch onto a nebulized LAMA therapy," Fadia wrote in a note to investors.
Fadia added that the key advantages for Yulperi are its once-daily dosing, as it simplifies things for patients on multiple medications, and its compatibility with standard jet nebulizers.
That's good news for Mylan's North American business, which has experienced falling segment sales and significant spending associated with remediation at its Morgantown, West Virginia, manufacturing plant.
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