AstraZeneca’s Daliresp (roflumilast) is now approved at 250 micrograms for the first four weeks followed by 500 mcg thereafter to treat patients with COPD.
This approval by the US FDA will help reduce the rate of discontinuation previously reported in patients undergoing Daliresp treatment.
The FDA based its ruling on results of the Phase 3 OPTIMIZE study (NCT02165826). The trial enrolled 1,323 patients with severe COPD associated with chronic bronchitis who had at least one exacerbation episode in the previous year. The 12-week trial compared the discontinuation rates of Daliresp in COPD patients divided into three experimental groups.