AstraZeneca PLC
23 September 2005
ASTRAZENECA SUBMITS NEW DRUG APPLICATION (NDA) TO FDA
FOR SYMBICORT(R) MAINTENANCE TREATMENT OF ASTHMA
AstraZeneca has announced submission of a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for approval of SYMBICORT(R) (budesonide/
formoterol) for the maintenance treatment of asthma.
SYMBICORT is a combination of budesonide (an inhaled corticosteroid) and
formoterol (a rapid and long lasting ss2-agonist). Combination products
containing an inhaled corticosteroid and a long-acting ss2-agonist are
recommended by the National Asthma Education and Prevention Program (NAEPP) of
the National Institute of Health for patients including those whose asthma is
uncontrolled on inhaled steroid therapy alone, or for patients whose asthma is
currently controlled on an inhaled steroid plus a separate inhaled long-acting
ss2-agonist.
The SYMBICORT NDA submission is based on 27 Phase I, II and III trials designed
to assess the efficacy and safety of SYMBICORT in a Metered Dose Inhaler (MDI).
This application will be for maintenance treatment of asthma in patients age
12 and above. The NDA submission seeks approval for two strengths of SYMBICORT
(80/4.5 and 160/4.5 microgram).
SYMBICORT is currently available in a dry powder inhaler device, Turbuhaler(R),
in 93 countries around the world. The current worldwide market for fixed
combination products is estimated to be worth over $6 billion, with
approximately half of this potential market in the U.S. SYMBICORT sales were up
21 percent in the first half of 2005, reaching $502 million. In 2003 it was
estimated that 20 million Americans had asthma. Of these, 11 million Americans
had an asthma attack.
23rd September 2005
For further Information:
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel + 1 212 579 0506
- Ends-
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