Single inhaler licence could boost Symbicort sales
Tuesday , June 21, 2005
Asthma patients taking Symbicort could dispense with all other inhalers if AstraZeneca is granted an extended licence for the drug. Symbicort (budesonide and formoterol) is a combination of a corticosteroid and a long-acting beta-2 agonist in one inhaler for long-term treatment, but patients must currently still use a 'reliever' inhaler short-acting beta-2 agonist in case of acute asthma attacks. AstraZeneca say new evidence proves the formoterol component is effective in treating these attacks as well, allowing patients to only carry a Symbicort inhaler. Symbicort's Single Inhaler Therapy (SiT) has already been approved in Brazil and the Philippines but the company withdrew filing for EU approval last year to wait for the new data. If approved, the licence would prove much more convenient for patients and could help AstraZeneca close the gap on GlaxoSmithKline's market leader Seretide. Symbicort and Seretide (salmeterol/fluticasone) are the only two corticosteroid/beta-2 agonist combination inhalers on the market, and can only be introduced when patients fail to respond to a short-acting beta-2 agonist and a corticosteroid (Step 3 of the current UK guidance from the British Thoracic Society and Scotland SIGN). The 2-in-1 formulations help cut the number of inhalers needed from three to two, but now AstraZeneca say its COSMOS study proves Symbicort patients need only one. It said Symbicort's formoterol has "a unique, rapid and long-lasting bronchodilator, which can be used both as a maintenance and reliever medication," a point it will try to prove to Europe's regulators later this year. In the 12 month head-to-head COSMOS trial AstraZeneca enrolled more than 2,100 patients with moderate to severe asthma to compare Symbicort as both a preventative treatment and a reliever against the use of Seretide and a separate reliever. The results showed Symbicort patients 25% less likely to have a severe asthma attack and needing 38% less rescue medication compared to Seretide and the reliever inhaler. Dr Dave Singh, senior lecturer at South Manchester University Hospitals Trust, said: "This is an important moment in the management of asthma. The Symbicort SiT concept empowers patients to take control of their own disease and the impressive results of the COSMOS study demonstrate the potential for this approach to significantly improve patient outcomes." Symbicort's 2004 global sales totalled $797 million, up 32% on 2003, compared to Seretide's 19% rise to $4.5 billion, where it continues to hold its position as GSK's biggest-selling product. In England, the NHS spent £39.5 million in 2004 on Symbicort, compared with £177.3 million on Seretide. A spokesman for GSK questioned whether AstraZeneca's product would receive European approval on this basis and said "neither Seretide or Symbicort are rescue therapies in our mind". Related articles: 'Smarter steroid' Alvesco launched in the UK Thursday , February 03, 2005
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