The U.K.' s National Institute for Clinical Excellence has put the brakes on Merck & Co.' s and partner Nycomed A/S' chronic obstructive pulmonary disease drug Daxas (roflumilast) for patients in the NHS in England and Wales, citing concerns over the high level of adverse incidents, uncertainties with the manufacturer's cost calculations and accuracy of trial evidence.
In its preliminary recommendations, NICE has left the door open for Daxas, but now wants the companies to conduct a further clinical trial. While the recommendations are a blow to Merck, serious rivals have not yet emerged into NICE's field of vision.
NICE's Appraisal Committee is asking for an additional trial to be conducted at the companies' expense, to provide more specific evidence in line with its EU authorization, granted on July 7, 2010, for adults with severe COPD associated with chronic bronchitis with a history of frequent exacerbations as an add-on to bronchodilator treatment.
It wants evidence about the benefits of roflumilast, a selective PDE-4 inhibitor, as an add-on to long-acting muscarinic antagonists (LAMA), plus long-acting beta2 agonists (LABA) and inhaled corticosteroids (ICS) -so-called trip therapy and the current standard of care in England and Wales - or LAMA or LABA for people who are intolerant to or decline ICS.
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