FDA OK's GSK's Arnuity Ellipta in asthma
This article was originally published in Scrip
The FDA on 20 August OK'd GlaxoSmithKline’s Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid maintenance treatment of asthma, as prophylactic therapy in patients 12 years or older.
GSK emphasized that Arnuity is not indicated for relief of acute bronchospasm.
The FDA approved Arnuity Ellipta at the 100mcg and 200mcg doses.
Arnuity Ellipta is administered once daily via the Ellipta dry-powder inhaler, which is the same device used across a range of other approved respiratory medicines in GSK’s portfolio, including Incruse Ellipta (umeclidinium), a long-term, once-daily, maintenance treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema; Anoro Ellipta, a combination of umeclidinium bromide 62.5mcg and vilanterol 25mcg, a long-acting beta2 agonist (LABA), which gained the FDA's approval this past December for the long-term, once-daily maintenance of airflow obstruction in patients with COPD, including chronic bronchitis or emphysema; and the firm's combination inhaled corticosteroid and LABA Breo Ellipta (fluticasone furoate/vilanterol inhalation powder), which won US approval a year ago (scripintelligence.com, 1 May 2014, 19 December 2014, 10 May 2013).
Arnuity Ellipta is GSK's first asthma treatment from its new portfolio to have gained approval in the US "and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patient," said Dr Darrell Baker, head of global respiratory franchise at the company.
The efficacy and safety of Arnuity Ellipta was evaluated in more than 3,600 patients with asthma.