GlaxoSmithKline and AstraZeneca have broadly welcomed the latest recommendations from a US Food and Drug Administration panel on the use of asthma medicines containing long-acting beta-agonists, though GSK is concerned about possible restrictions on the use of Serevent.
An FDA advisory panel backed the use of GSK’s Advair/Seretide (salmeterol/ fluticasone) for children, adolescents and adults, while AstraZeneca’s Symbicort (formoterol/ budesonide) has been recommended for adolescents and adults. However the joint committee said that the risks of GSK’s Serevent (salmeterol) and Schering-Plough’s Foradil (formoterol) outweighed their benefits. The two drugs contain LABAs only, while Advair and Symbicort combine them with an inhaled corticosteroid.
Regarding Serevent and Foradil, the panellists did not recommend that the drugs be withdrawn from the market but several suggested that the products’ labels be reworded to specify that they should be used in conjunction with an ICS, as per current treatment guidelines.
Ellen Strahlman, GSK’s chief medical officer, said that “we welcome the committee’s endorsement of Advair as a safe and effective treatment for asthma in adults and children.” As for Serevent, she added that “our proposed new labelling, medication guide and risk management plan” would help physicians safely manage the appropriate use of Serevent in conjunction with an ICS”.
However Dr Strahlman said that “we are concerned that if the FDA adopts the panel’s recommendation…it is possible that Serevent would be severely restricted and deny patients needed treatment for optimal care of their asthma.” Meanwhile her counterpart at AstraZeneca, Howard Hutchinson, said the safety and efficacy of Symbicort have been demonstrated in “numerous clinical trials and from extensive post-marketing use around the world. We are pleased that the joint advisory committees’ recommendation confirms our view”.
