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Merck's COPD drug rejected by NICE

Published on 15/09/11 at 12:29pm
Merck & Co

NICE has not recommended Merck Co’s Daxas and has advised the firm to conduct a clinical trial in order to generate more data.

In draft guidance NICE’s independent appraisal committee doubted that Daxas (roflumilast) reduces the rate of exacerbations as an add-on to triple or dual therapy for people with severe COPD.

Professor Carole Longson, NICE’s Health Technology Evaluation Centre director, said: “While we recognise it is important for people with severe COPD to have a range of options, NICE has to ensure that the NHS provides treatments which are effective and value for money. We hope a clinical study would generate robust evidence so that we can be clear about the benefits roflumilast brings for these patients.”

According to NICE there are currently 1 million people with COPD in England and Wales, and it is estimated that almost 200,000 would be eligible for treatment with roflumilast by 2015. Likely treatment duration would be many years.

Longson added: “We encourage Merck, Sharp & Dohme, patient organisations and other relevant third parties to comment on this preliminary recommendation during this public consultation period so that they can contribute to the development of this guidance."

Daxas is known as Daliresp in the US where it was approved in March this year. Final guidance from NICE on its use by UK health service is expected in January 2012.

Brett Wells

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