UPDATE 1-Mylan and Theravance’s COPD treatment gets FDA approval


(Reuters) – Theravance Biopharma Inc and partner Mylan NV on Friday won U.S. regulatory approval for their treatment for a chronic lung condition that causes breathing-related problems.

The treatment, Yupelri here, is a once-daily inhalable solution to be used by patients of chronic obstructive pulmonary disease (COPD), a lung disease characterized by wheezing or chronic cough.

Yupelri belongs to a class of drugs called long-acting muscarinic antagonists (LAMA), with the existing treatment options primarily being hand-held devices.

About 9-10 percent of COPD patients in the United States prefer a nebulized product for maintenance therapy, Raymond James analyst Elliot Wilbur said in a note prior to the approval.

COPD is a collective term for a group of lung diseases commonly triggered by long-term smoking and exposure to air pollutants. The World Health Organization predicts COPD to become the third leading cause of death worldwide by 2030.

Mylan’s shares fell 1 percent to $36.70, while Theravance rose 5.7 percent to $26.07.

Reporting by Manogna Maddipatla in Bengaluru; Editing by Maju Samuel

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