First-in-class approved for COPD

Nycomed’s novel anti-inflammatory roflumilast will soon be available in the EU following a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use.

Roflumilast, an orally active phosphodiesterase-4 inhibitor, has an active metabolite that modifies the function of a wide range of cells contributing to inflammatory change. The recommended dose is 500mg once daily.
Two one-year phase 3 trials involving over 3000 patients with severe or very severe COPD have shown that roflumilast improves lung function and reduces moderate to severe exacerbations. It has also been shown to be effective when added to treatment with a long-acting bronchodilator such as salmeterol and tiotropium in patients with moderate COPD.
Roflumilast will be marketed in Europe later this year under the brand name Daxas.