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Trelegy Ellipta: Triple therapy inhaler for COPD approved by FDA




The US Food and Drug Administration (FDA) has approved a new once-daily single inhaler triple therapy for treatment of certain adults with chronic obstructive pulmonary disease (COPD). 

Trelegy Ellipta (furoate, umeclidinium, vilanterol) is indicated for patients on a fixed-dose combination fo fluticasone furoate and vilanterol for airway obstruction, and for reducing exacerbations in those who need additional treatment for airflow obstruction, or for patients receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. However, the product is not indicated for treating asthma or for acute bronchospasm.

COPD is the term given to a group of conditions causing airflow blockage and respiratory problems, including emphysema, chronic bronchitis, and occasionally asthma. More than 15 million Americans are diagnosed with COPD, according to the Centers for Disease Control and Prevention (CDC). Those at high risk of COPD include people over 65 years of age, those with a history of asthma, and current or former smokers. 

A number of combination inhalers are already available in the United States, such as the Advair Diskus (fluticasone, salmeterol), a combination b2-stimulant and corticosteroid, and the Anoro Ellipta, an anticholinergic combination with B2-stimulants. However, the Trelegy Ellipta, manufactured by GlaxoSmithKline and Innoviva Inc, is the first product to feature a triple therapy with an inhaled corticosteroid, long-acting muscarinic antagonist, and a long-acting beta2-adrenergic agonist.  

Mike Aguiar, chief executive officer of Innoviva, stated: “This approval represents a significant therapeutic convenience for those appropriate patients already on Breo Ellipta, that require additional bronchodilation or for those patients already on a combination of Breo Ellipta and Incruse Ellipta.”

Who should not take Trelegy Ellipta? 

  • Trelegy Ellipta is contraindicated in patients with severe hypersensitivity to milk protein or any of the ingredients. 
  • Patients with acutely deteriorating COPD. 

Common Side Effects of Trelegy Ellipta

  • Headaches 
  • Back pain
  • Altered taste
  • Diarrhea
  • Cough
  • Mouth pain
  • Gastroenteritis (stomach flu)

In November 2017, GlaxoSmithKline submitted a regulatory application for FDA approval of another drug to treat patients with COPD. It submitted phase III data to support its application for approval of mepolizumab, an interleukin-5 antagonist used as an add-on to maintenance treatment of COPD.

Trelegy Ellipta will be available in American pharmacies in the coming months. For more information on Trelegy Ellipta, visit https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Trelegy/pdf/TRELEGY-PI-MG-IFU.PDF