FDA Approves GSK's Asthma Drug Arnuity Ellipta

The U.S. Food and Drug Administration (FDA) has approved GlaxoSmithKline’s Arnuity Ellipta, a once-daily inhaled corticosteroid (ICS) maintenance treatment for asthma in patients 12 years and above.

Arnuity Ellipta is a fluticasone furoate inhalation powder approved in 100mcg and 200 mcg strengths. The medicine is administered once daily using the dry powder inhaler Ellipta, which is also part of other approved respiratory drugs offered by GSK. Last month GSK and Theravance filed an application to the FDA for fluticasone furoate/vilanterol, under the brand name Breo Ellipta, in asthma.

Darrell Baker, SVP and Head of GSK Global Respiratory Franchise, said, “The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the U.S. and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients.”

Asthma is a chronic lung disease characterized by the inflammation and narrowing of the airways. The root of asthma is not well understood but it is believed to be caused by an interaction between a patient’s genetic makeup and their environment. Inhaled substances, such as dust or pollen, play a key part in inducing allergic reactions and irritation of the airways. An estimated 26 million people in the U.S. are affected by asthma around the world, more than half of whom still experience poor control of their disease.

The approval was based on positive results from clinical trials involving more than 3,600 patients with asthma. The drug may cause upper respiratory infection, headache, nasopharyngitis, or bronchitis as adverse events. Arnuity Ellipta is not recommended as primary treatment of status asthmaticus or acute episodes of asthma necessitating intensive measures. The drug is also no intended for patients who are severely sensitive to milk proteins or any other components of Arnuity Ellipta.