Anglo-Swedish drugmaker AstraZeneca has submitted a New Drug Application to the US Food and Drug Administration seeking approval to market its Symbicort (budesonide/formoterol) for the maintenance treatment of asthma in patients aged 12 and above.
The NDA is based on safety and efficacy data from a total of 27 Phase I, II and III trials, which evaluated the agent in a metered dose inhaler.
Symbicort is already available in a dry powder inhaler device, Turbuhaler, in 93 countries around the world outside of the USA, competing with UK drug giant GlaxoSmithKline’s Advair (fluticasone propionate/salmeterol), which generates annual sales of around $4.5 billion. Marketing clearance in the USA should substantially boost Symbicort’s already robust growth – for the first half of 2005, the drug’s revenues jumped 21% to $502 million.
According to AstraZeneca, the current global market for fixed combination products is estimated at over $6 billion, with about half of this potential market in the USA alone.
