European Medicines Agency to approach GSK after respiratory pharmacists raise concerns about Relvar Ellipta
GSK defends its new inhaler after letter to The Pharmaceutical Journal prompts action from European Medicines Agency
The European Medicines Agency says it will approach GlaxoSmithKline to flag concerns raised by a group of respiratory pharmacists over the potential for dosing errors with a new inhaler for asthma and chronic obstructive pulmonary disease.
The move comes after the group of expert respiratory pharmacists queried the dosing and the appearance of GSK’s Relvar Ellipta in a letter written to The Pharmaceutical Journal. The seven experts question why the inhaler, which contains either 92µg or 184µg fluticasone furoate and 22µg vilanterol, is licensed for patients requiring a low- to mid-dose of inhaled corticosteroid (ICS) when 92µg fluticasone furoate is equivalent to 250µg of fluticasone proprionate twice daily. They point out that this is a medium dose and “is actually at the top of the dose response curve in asthma”. They add: “Consequently, Relvar Ellipta is not appropriate for patients at step 3 of the British Thoracic Society and Scottish Intercollegiate Guidelines Network asthma guidelines”.
In response, GSK argues that clinical trials involving thousands of patients have shown the inhaler is appropriate for patients on a low-mid dose of ICS, adding that there is no absolute threshold dose when initiating add-on therapy. The company explained to The Journal that the clinical trials for the inhaler involved patients who were not well controlled at step 2 (regular inhaled steroid and as needed short-acting ß2 agonist) and needed to go up to step 3 (ICS and long-acting ß2 agonist). The EMA told The Journal that the indication for this medicine is consistent with the draft revised EU asthma guideline and the guideline on fixed-dose combination products.
The respiratory pharmacists also point out in their letter that reliever inhalers are traditionally blue and preventer inhalers brown, red or purple. They argue that the blue colour of the inhaler and the name Relvar might confuse patients into thinking it was a reliever inhaler and not a once-daily maintenance inhaler.
The EMA told The Journal that there is no EU-wide convention on colour coding for inhalers. However, it added: “The EMA will approach the marketing-authorisation holder to flag this issue raised in the UK and will closely follow up the matter with the company.” The medicines regulator also told The Journal that if safety concerns were reported, for example medication errors, it would be in a position to adjust its recommendations on the medicine.
“Any name-related potential safety risks or public health concerns identified post-authorisation could lead to reconsideration of the acceptability of invented names,” said the medicines regulator.
Asked whether it would consider changing the colour or name of the product, GSK said that all reports regarding safety are responded to quickly and that product safety is an ongoing assessment. GSK said that during clinical trials, no safety concerns had been raised about the colour or name of Relvar Ellipta. The company argues that because most reliever inhalers are metered dose inhalers and Relvar is a dry powder inhaler with a different design and mechanism, it would be unlikely for a patient to confuse Relvar Ellipta with a reliever inhaler.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11134711
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