Posted by Michael Wonder on 27 Jan 2018
Daliresp receives US FDA approval for 250 mcg starting dose for patients with severe COPD
24 January 2018 - Study shows Daliresp 250 mcg as a starting dose for the first four weeks followed by 500 mcg thereafter, demonstrated a 25% reduction in the percentage of patients discontinuing treatment compared to Daliresp 500 mcg for 12 weeks.
AstraZeneca today announced the U.S. FDA has approved Daliresp (roflumilast) 250 mcg as a starting dose once daily for the first 4 weeks of treatment followed by 500 mcg thereafter to help reduce the rate of treatment discontinuation in some patients. Daliresp is currently indicated for reducing the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
The 250 mcg dose approval was based on data from the Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250 mcg and 500 mcg, as add-on to Standard COPD Treatment to Treat Severe COPD (OPTIMIZE) study.
