Symbicort approved for reduction of COPD exacerbations

The FDA has approved a supplemental NDA for AstraZeneca’s Symbicort budesonide/formoterol fumarate MDI extending its use to include the reduction of COPD exacerbations. The sNDA, which was approved on September 11, 2017, included supporting data from two Phase 3b studies according to AstraZeneca.

In August 2016, AstraZeneca announced positive results from the RISE (Revealing the Impact of Symbicort in reducing Exacerbations in COPD) study and said that it was considering a regulatory submission based on data from that study.

Data from the CHASE 3 (ChildHood Asthma Safety and Efficacy) study were announced at the same time, and in January 2017, the FDA approved an sNDA for the use of Symbicort for pediatric patients patients,

Symbicort was initially approved by the FDA in 2006, and 17 supplemental NDAs for the product have been approved subsequently.