WORLD NEWS | JUNE 30, 2014 1
SELINA MCKEE
GlaxoSmithKline and Theravance are seeking approval in the US to market their COPD inhaler Breo Ellipta (fluticasone furoate/vilanterol) for patients with asthma as well.
The drugmakers said they have filed a supplemental New Drug Application with the FDA for the inhaled corticosteroid/long-acting beta2 agonist as a treatment for asthma in patients aged 12 years and over.
Despite medical advances, more than half of patients with asthma continue to experience poor control and significant symptoms, and the firms will be hoping that their product will help address some of this unmet need, while giving sales a nice little boost at the same time.
US officials issued Breo Ellipta with a green light in May last year for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, while in Europe it has been approved (as Relvar Ellipta) for both asthma and COPD.
SELINA MCKEE
GlaxoSmithKline and Theravance are seeking approval in the US to market their COPD inhaler Breo Ellipta (fluticasone furoate/vilanterol) for patients with asthma as well.
The drugmakers said they have filed a supplemental New Drug Application with the FDA for the inhaled corticosteroid/long-acting beta2 agonist as a treatment for asthma in patients aged 12 years and over.
Despite medical advances, more than half of patients with asthma continue to experience poor control and significant symptoms, and the firms will be hoping that their product will help address some of this unmet need, while giving sales a nice little boost at the same time.
US officials issued Breo Ellipta with a green light in May last year for the long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, while in Europe it has been approved (as Relvar Ellipta) for both asthma and COPD.