AstraZeneca Announces Symbicort® Is Now Available In The U.S.

AstraZeneca today announced that SYMBICORT® (budesonide/formoterol) pressurised Metered Dose Inhaler (pMDI) is now available in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Administered twice daily, SYMBICORT pMDI is a combination of two proven asthma medications – budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta agonist (LABA). This combination treatment offers patients improved asthma control as early as day one that is sustained over 12 weeks. U.S. studies have also demonstrated that SYMBICORT pMDI delivers a significant improvement in lung function within 15 minutes of beginning treatment.

SYMBICORT pMDI is approved for patients whose disease is not adequately controlled on another asthma-controller medication or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. SYMBICORT pMDI is available in two dose strengths, 80/4.5 and 160/4.5 µg of budesonide and formoterol, respectively.

“The U.S. availability of SYMBICORT holds great promise for millions of Americans that suffer from asthma,” said Tony Zook, President and Chief Executive Officer, AstraZeneca in the U.S. “The addition of SYMBICORT to our U.S. respiratory portfolio reinforces AstraZeneca’s commitment to developing new, effective treatments, and provides patients and physicians with a treatment option that will help control patients’ asthma and improve and maintain lung health.”

Asthma is one of the most serious chronic medical conditions in the U.S. and it is estimated that around 20 million Americans suffer from asthma. In fact, 11 Americans die from asthma each day, which translates to more than 4,000 asthma deaths each year, many of which are avoidable with proper treatment and care.

SYMBICORT pMDI was approved by the U.S. Food and Drug Administration on July 21, 2006. The SYMBICORT pMDI submission was based on 27 Phase I, II, and III trials designed to assess the efficacy and safety of SYMBICORT in a pMDI. The approved indication is largely based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients in the U.S., age 12 and older with asthma. These studies showed that both dosage strengths of SYMBICORT pMDI produced a greater improvement in lung function compared to the same doses of budesonide or formoterol administered alone or placebo. In addition, these studies demonstrated a more rapid improvement in lung function compared to budesonide and placebo. Clinically significant improvement in bronchodilatory response, or opening of the lung airways, occurred within 15 minutes of beginning treatment with SYMBICORT pMDI.

The safety of SYMBICORT pMDI is based on a robust U.S. development programme, which evaluated safety in over 6,000 patients treated with SYMBICORT pMDI in Phase I, II and III studies that were submitted to the FDA. SYMBICORT pMDI has safety data from long-term studies up to one year and a robust cardiac safety profile. In the US, as with all LABA-containing products on the market, Symbicort pMDI carries a boxed warning as requested by the FDA.

Symbicort® Turbuhaler (Dry Powder Inhaler) is already approved for treatment of asthma and/or COPD in more than 90 countries. Symbicort full year sales for 2006 reached $1,184 million. AstraZeneca has also demonstrated its commitment to the respiratory area through a novel research and development programme for Symbicort Turbuhaler, which has resulted in the development and approval of SYMBICORT® Maintenance and Reliever Therapy (Symbicort® SMART), in Europe and certain other countries outside the US.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.