After several delays, AstraZeneca’s Symbicort asthma inhaler has been launched in the US, making it the second ICS/LABA combination available in this market. However, its late entry and lack of approval for the SMART indication means it will face tough competition from GlaxoSmithKline’s Advair which currently dominates the respiratory market.
AstraZeneca’s Symbicort (budesonide/formoterol) pressurized metered dose inhaler has been launched in the US for the long-term maintenance treatment of asthma in patients 12 years of age and older. Although Symbicort was approved by the FDA in July 2006, its release was delayed in order for the company to increase manufacturing capacity to meet market demand.
The only other fixed dose inhaled corticosteroid (ICS) and long acting beta agonist (LABA) combination product on the US and EU markets is GlaxoSmithKline’s Advair (fluticasone/salmeterol), which is marketed as Seretide in Europe. This drug is approved for the maintenance treatment of asthma in patients aged four years and older and patients with chronic obstructive pulmonary disease (COPD).
Symbicort has been available in Europe since 2001 and an additional approval for the SMART indication (Symbicort maintenance and reliever therapy) was gained in this market in 2006. With the SMART approach, Symbicort is used to provide a stable dosing regime, as with Advair, but the dose can be increased during an exacerbation of symptoms instead of using short-acting rescue bronchodilators.
While this is key to differentiate Symbicort from Advair, AstraZeneca has stated it will not pursue this indication extension in the US in the medium-term. It will seek pediatric and COPD indications instead, in order to compete with Advair in these patient populations.
Advair has dominated the EU asthma and COPD market since it was launched in 1998, accounting for approximately 67% of total sales of the ICS/LABA class and 28% of the total respiratory market. Symbicort in comparison only holds 32% share of the ICS/LABA class and 13% of the total market.
In the US, GSK’s Advair has been in a monopoly position for several years, which will make it difficult for AstraZeneca to gain market share. In addition, several new ICS/LABA combinations are expected to hit the market by 2016, which will put further pressure on Symbicort. One such treatment, Chiesi’s Foster, has been approved in the EU and was launched in Germany in 2006.
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