FDA grants AstraZeneca six months paediatric exclusivity for Symbicort

The US Food and Drug Administration has granted AstraZeneca six months of paediatric exclusivity for its Symbicort inhalation aerosol for asthma.

The decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a written request.

Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of chronic obstructive pulmonary disease in adults.

The inhalation aerosol was first launched in Sweden in 2000 and has been approved in around 120 countries to treat asthma and/or COPD either.

At 1210 GMT, AZN shares were up 1.5% to 4,326.50p.