GlaxoSmithKline has announced that the FDA has approved fluticasone furoate inhalation powder, as a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as preventative therapy in patients 12 and up. This therapy is only intended to prevent an asthma attack, not to treat it once it happens. For treating an asthma attack, one would still need a rescue inhaler.
The approved doses of the fluticasone furoate inhalation powder, marketed as Arnuity Ellipta, are 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.
Last year, the FDA approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
The market for asthma drugs is predicted to reach $18 billion by 2021, according to new research. With six products forecast to launch, the research estimates the asthma market in the USA, Japan, and five major European Union markets (France, Germany, Italy, Spain and the UK), will grow at a rate of 1.4% by 2021.
Darrell Baker, SVP & Head, 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 US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients.”
The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma. The most common side effects (reported in at least 5% of people) were upper respiratory tract infection, common cold, headache, and bronchitis. Side effects are similar to those of other inhaled steroids. For example, some people may develop a yeast infection in their mouth. Those with a severe milk allergy should not use this drug. Close monitoring for glaucoma and cataracts is also needed, the company says.
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