AstraZeneca asthma drug approved in EU

AstraZeneca has been granted European Union marketing approval forSymbicort (budesonide plus formoterol), a new drug for asthma, under the mutual recognition procedure. This follows initial approval in Sweden last year (Marketletter September 4, 2000) and, more recently, registration in Switzerland. It has also been submitted for approval in Canada and Australia.

Using the two compounds in combination has been shown to reduce the rate of severe asthma attacks in patients with moderate-to-severe asthma by 26%-63%, with mild attacks being reduced by up to 62%.

It has been suggested that this product is more versatile than rival combination product Seretide (fluticasone plus salmeterol) from GlaxoSmithKline because the dosage of the two drugs can be adjusted within the same inhaler, allowing the prescriber to tailor maintenance treatment using a single inhaler device. "Symbicort is the first and only inhaler containing a corticosteroid and a rapid and long-lasting bronchodilator that provides prescribers with the unique benefit of being able to start at a high dose and then, depending on how the patient responds, step down or back up using the same single inhaler," said the firm.