The European Medicines Agency (EMA) has granted pharmaceutical firm GlaxoSmithKline (LON: GSK) and Innovia marketing authorisation for their single inhaler triple therapy Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), Pharma File reported on Thursday.
Trelegy Ellipta is used in the treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
It has also been indicated for patients who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired, or for those who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.
Trelegy Ellipta is the first approved treatment of its kind as it combines three active molecules in the treatment of COPD: inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist.
"COPD is a progressive disease that can worsen over time, and represents a significant burden to patients and healthcare systems," commented Eric Dube, senior vice president & head of GSK's Global Respiratory Franchise.
"The approval of Trelegy Ellipta, and the addition of a once-daily single inhaler triple therapy to our portfolio of respiratory medicines, is an important milestone for GSK that builds on our long heritage in this area."
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