Glaxo asthma drug safe for adults, not adolescents
GlaxoSmithKline Plc’s drug to treat chronic breathing problems is safe and effective enough to be approved in adults with asthma, but not adolescents, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday.
The panel voted 16-4 that the product, Breo Ellipta, should be approved for once daily treatment of asthma in adults 18 years and older. It voted 19-1 that the data did not support approval for use in children aged 12 to 17.
The FDA is not obliged to follow the advice of its advisory panels but typically does so. Glaxo licensed the product from Theravance Inc in 2002.
The panel recommended that a large safety trial be conducted similar to others being conducted for drugs in the same class in both adolescents and adults.
Breo Ellipta is an inhaled treatment that has already been approved to treat chronic obstructive pulmonary disease, or COPD, a condition that includes emphysema, chronic bronchitis, or both.
The drug consists of a corticosteroid, which reduces inflammation, and a long-acting beta-agonist, or LABA, called vilanterol, which is designed to open the airways.
The LABA class of drugs has been linked in the past with asthma-related deaths, although there were no asthma-related deaths in studies of Breo Ellipta reviewed by the FDA.
Category: Features, Health alert
