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Drug for chronic obstructive pulmonary disease approved by NICE

Roflumilast (Daxas) has been approved by the National Institute of Health and Care Excellence (NICE) for the treatment of individuals with chronic obstructive pulmonary disease (COPD).

The drug, which is recommended as an option to treat adults with severe COPD whose symptoms continue to worsen despite other treatments, was initially reviewed by England’s health technology assessment body in 2012. However, limited data meant it was recommended only for patients participating in clinical trials.

Since then, two new trials have highlighted the effectiveness of roflumilast in easing hard-to-treat COPD symptoms, and consequently NICE decided to reviewed its guidance and to approve the drug — meaning that 122,000 eligible adults in England will now be able to receive it.

“This will be welcome news for many patients who have severe COPD symptoms that have been difficult to control,” says Carole Longson, director of the NICE centre for health technology evaluation. “COPD is a chronic lung condition which causes breathing problems and for many, symptoms will only worsen with time.”

Providing there are no appeals or factual inaccuracies raised by registered organisations, the final guideline will be published in July 2017 and roflumilast will be made available on the NHS within three months.

The US Food and Drug Administration approved the use of roflumilast for reducing COPD exacerbations in the USA in March 2011.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203049

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