AstraZeneca submits application for asthma treatment

Source: Healthcare Digital

Date :04/06/2008 11:44:31

AstraZeneca announced today that it submitted a New Drug Application for approval of SYMBICORT for the treatment of asthma in children

The application was made to the US Food and Drug Administration as the drug is currently used for the long-term maintenance treatment of asthma in patients 12 years of age and older.

If the new indication for SYMBICORT is approved, the inhalation aerosol will be used to treat asthma in paediatric patients aged between six and 11 years.

Long-term treatment option

The submission package is based on a clinical development program consisting of five active or placebo-controlled Phase III trials which assess the efficiency and safety of SYMBICORT inhalers. The clinical trials were carried out on 1,446 children aged six to 11 years old with asthma.

The most adverse events reported by the trial were headache, pyrexia, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.

Lead investigator Jeffrey Leflein, of the Allergy & Immunology Associates of Ann Arbor, said, “Millions of children in the US are affected by asthma. SYMBICORT could potentially offer another treatment option for the long-term maintenance of asthma in young children whose condition is not controlled with inhaled corticosteroids alone.”

June 4, 2008