The United Kingdom’s National Institute for Health and Care Excellence (NICE) recently approved Daxas (roflumilast), developed by AstraZeneca, as a treatment for chronic obstructive pulmonary disease (COPD).
The new indication could potentially benefit about 122,000 adults in the U.K. who are estimated to be eligible to receive Daxas, according to NICE, which is part of the National Health Service (NHS).
“COPD is a chronic lung condition which causes breathing problems and for many, symptoms will only worsen with time,” Carole Longson, director of the NICE Centre for Health Technology Evaluation, said in a press release.
“New evidence has meant we can now say that roflumilast should be routinely available to patients with severe COPD. This will be welcome news for many patients who have severe COPD symptoms that have been difficult to control,” Longson said.
Daxas is an orally administered long-acting selective phosphodiesterase-4 enzyme inhibitor. It targets cells and mediators believed to be important in COPD. The drug can reduce irritation and swelling in the airways of COPD patients.
When NICE first reviewed Daxas in 2012, limited data was available on the drug, and NICE would only recommend the treatment if patients were taking part in a clinical trial. After two new trials showed the drug could ease symptoms that couldn’t be managed with inhalers, NICE reconsidered its first guidance and approved Daxas treatment for eligible patients outside clinical trials.
Evidence supporting this decision came from studies including the Phase 4 REACT clinical trial (NCT01329029) that included 1,935 patients with severe COPD associated with chronic bronchitis and a history of frequent exacerbations.
Daxas is recommended as a maintenance treatment for severe COPD when adult patients have a forced expiratory volume in one second (FEV1; a measure of lung function) less than 50 percent predicted and a history of frequent exacerbations. Daxas is to be used as an add-on therapy to bronchodilator treatment.
The most common adverse reactions associated with Daxas treatment include diarrhea, weight loss, nausea, abdominal pain, and headache.
The draft guidance will now receive requests for appeals or requests to revise factual inaccuracies. If there are no appeals, the final guideline will be released in July 2017 and Daxas will become available through the NHS within three months of the release date.