AstraZeneca is developing new labelling for its combination asthma medication Symbicort that could boost its prospects against rival drug Seretide/Advair from GlaxoSmithKline, according to Datamonitor.
The new dosing approach will allow patients to increase the dose of Symbicort (budesonide and formoterol) when their asthma is bad, helping them relieve symptoms more effectively and reducing the severity of attacks. The regimen – known as SMART (Symbicort Maintenance and Reliever therapy) – could be approved in Europe later this year.
“SMART [could] provide a major incentive for physicians to switch patients from … Seretide and be a significant barrier to entry of new competitors, which may have to offer variable dosing in order to compete with Symbicort,” said Datamonitor.
AstraZeneca filed for approval of SMART in Europe in November 2003but withdrew the application a year later as a result of discussions during the Mutual Recognition Process, said Datamonitor respiratory senior analyst Shaun Falkingbridge.
A new filing will include data from two additional studies, known as COSMOS and SMILE, which compare the use of Symbicort as maintenance and reliever medication compared to traditional Symbicort or Seretide (fluticasone and salmeterol) stable dosing regimes, he added.
Datamonitor notes that in 2004, the value of the combination asthma market in the five major European markets was $1.8 billion, with Symbicort holding a 27% market share. This could increase to 38% by 2008, with sales of over $1.2 billion, with the benefit of the new label.
Thereafter, competition will increase dramatically as new combinations are launched which may offer improvements in safety and compliance benefits such as once-daily dosing. But SMART could be a significant barrier to entry of new competitors, which may have to offer variable dosing in order to compete with Symbicort, according to the firm.