Post-marketing safety studies for LABAs: AstraZeneca confident of SYMBICORT in treatment of asthma

On March 10-11, 2010, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) -- including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees -- discussed the design of post-marketing safety studies for long-acting beta-agonist (LABA)-containing products in the U.S., including SYMBICORT^® (budesonide/formoterol fumarate dihydrate).

"As we've witnessed over the past two days, there are many challenges in designing and executing a relevant, feasible and ethical post-marketing safety study that answers FDA's question regarding LABA-containing products," said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca.  "AstraZeneca (NYSE: AZN) is confident in the positive benefit-risk profile of SYMBICORT in asthma as demonstrated by extensive clinical data and patient experience, and supports ongoing scientific discussion to address any outstanding questions regarding the use of combination LABA and inhaled corticosteroid products for the treatment of asthma.  We look forward to working with the FDA to execute a study design that is both scientifically robust and offers a pragmatic approach to answer critical questions regarding the appropriate use of LABAs." 

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters.  While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering decisions on public health matters.

SOURCE AstraZeneca