GlaxoSmithKline's Advair Diskus has been approved by the FDA for the treatment of severe cases of chronic obstructive pulmonary disease (COPD), the fastest growing treatment area of the highly competitive respiratory market.

Asthma treatment Advair (known as Seretide in the UK) is GSK's biggest selling drug, with third quarter sales of £552 million this year, and it already benefits widely from off-label prescribing for COPD.

Estimates place the level of such prescribing for Advair at 15-20% and because of this analysts have been cautious about predicting hugely improved sales for the drug.

The approval is good news for the company which suffered a setback in October when the US approval of its new COPD drug Ariflo was delayed by FDA requests for further data on a number of issues.

The regulators requested additional safety and efficacy data on the drug after its Pulmonary-Allergy Drug Products advisory committee voted seven to three against recommending Ariflo.

The committed voiced concern that mesenteric arteritis inflammation of a membrane in the abdomen observed in some clinical trial patients had not yet been adequately studied.

One member of the committee, Dr Christina Surawicz, said on voting: "I don't think it is a concern now but I can't promise that it isn't going to be a concern in the future so it is something that needs to be watched.

It remains unclear whether the company will have to conduct further trials of the drug before it can be approved.

Ariflo is a selective PDE4 inhibitor, a new class of drugs that also includes Pfizer's and Altana's Daxas (roflumilast), which those companies intend to file for EU approval in COPD towards the end of this year.

COPD refers to a variety of chronic lung disorders, most often a combination of chronic bronchitis and emphysema, which usually occurs in patients with a long history of heavy cigarette smoking.

The disease is currently the fourth leading cause of death in the US and is expected to become the third highest worldwide by 2020.

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