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FDA Approves Single Inhaler Triple COPD Therapy

GSK news release; 2017 Sep 18

The FDA has approved Trelegy Ellipta (GSK, Innoviva) single-inhaler triple chronic obstructive pulmonary disease (COPD) therapy.

Indications: Trelegy Ellipta (fluticascone/furoate/umeclidinium/vilanterol) is indicted for the long-term, once-daily, maintenance treatment of certain patients with COPD, including chronic bronchitis or emphysema, who are on the 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 patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

Dosage/administration: 1 inhalation once daily as maintenance treatment of COPD.

Adverse reactions: The most common adverse reactions (incidence ≥1%) are headache, back pain, dysgeusia, cough, oropharyngeal pain, and gastroenteritis.

Citation:

Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US. [news release]. GlaxoSmithKline: London, UK. http://us.gsk.com/en-us/media/press-releases/2017/trelegy-ellipta-approv.... Accessed September 18, 2017.