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Questions raised about affordability of asthma antibodies

Positive data on GSK and Teva anti-IL-5 candidates at ERS congress highlights cost concerns

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Data presented this week on interleukin-5 (IL-5) targeting antibodies proved their clinical value in asthma, but their affordability is already being questioned.

GlaxoSmithKline (GSK) and Teva presented positive phase III trials of their respective anti-IL-5 candidates mepolizumab and reslizumab at this week's European Respiratory Society (ERS) meeting in Munich, showing that they dramatically reduced breakthrough attacks when added to background therapy for people with severe asthma.

GSK presented data from two studies of mepolizumab - one in patients with severe asthma indicating a 50% drop in exacerbations and another showing that the drug can be used to reduce corticosteroid use - and says it is on track to submit the antibody for approval before the end of the year.

Teva meanwhile reported phase III data at the ERS showing lung function improvements with reslizumab and has said it should be in a position to file in the first half of 2015, while a third candidate, benralizumab from AstraZeneca, is a few months further back in development.

There is much anticipation about the new class because despite the availability of several drug classes such as beta agonists, corticosteroids, leukotriene antagonists and Novartis' anti-immunoglobulin E antibody Xolair (omalizumab), around 10% of asthma patients still struggle to control their symptoms.

Many patients with uncontrolled asthma have to take oral doses of corticosteroids, which can have serious side effects such as weight gain, diabetes, high blood pressure and glaucoma and may also have to be hospitalised for breakthrough attacks.

Anti-IL-5 drugs are thought to work by depleting the body of eosinophils, a type of white blood cell linked to exacerbations in asthma, and so are only suitable for patients with elevated levels of these cells measured by a sputum test or, according to new data presented by GSK at ERS, a blood test.

There are around 235 million people with asthma worldwide, equating to more than 20 million individuals with uncontrolled symptoms and an estimated 2 million patients with elevated eosinophils. With the price of the new antibody therapies predicted by analysts to be upwards of $10,000 a year, widespread use of the drugs could place a hefty additional burden on the management of a disease currently managed mainly with generic drugs.

Analysts have predicted that the class as a whole could be worth $7.5bn a year at peak, while other biologics coming through the pipeline, such as Sanofi and Regeneron's IL-4 and IL-13 targeting dupilumab and AZ's IL-13-targeting tralokinumab, could add to the tally, particularly if data starts to emerge suggesting they are clinically beneficial in combination.

GSK and Teva are certainly not talking about pricing yet, but an editorial in the New England Journal of Medicine by asthma specialist Parameswaran Nair of Canada's McMaster University is already suggesting that their use should be limited.

He points out that data from GSK's trials suggests that boosting adherence to current drugs such as inhaled corticosteroids and beta agonists helped to cut exacerbations by half, in what is likely to be a much more cost-effective way than adding in an expensive biologic drug.

"This finding would suggest that most patients in this clinical trial might have had improvement in symptoms without mepolizumab simply by the institution of good clinical practice, as recommended by current international guidelines," he writes, although he adds that the effect of mepolizumab in reducing oral steroid use is "an important advance."

"It is reasonable to consider anti–IL-5 therapy for patients with severe asthma who are receiving high doses of systemic glucocorticoids and who continue to have an elevated eosinophil count, he concludes.

GSK meanwhile says it is confident that pharmacoeconomic studies will prove the worth of biologics in reducing hospitalisations and the significant morbidity associated with oral steroid use.

Article by
Phil Taylor

10th September 2014

From: Research, Sales

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