Frank Trudo, MD, MBA, was recently appointed as VP, US Respiratory, Medical Affairs, at AstraZeneca.
Frank Trudo, MD, MBA
Frank Trudo, MD, MBA, was recently appointed as VP, US Respiratory Medical Affairs at AstraZeneca.
You’ve had an interesting career in that you’ve been both a practicing pulmonologist seeing patients every day and a medical expert involved in drug development at AstraZeneca. Take me through your career path and what led you to your current role as VP of US Respiratory, Medical Affairs at AstraZeneca.
I decided to go into pulmonary medicine because I was interested in the multifaceted approach of the specialty across immunology, infectious disease, and oncology. I did my pulmonology specialty training at the University of Pennsylvania and then joined a practice. After 13 years as a practicing pulmonologist, I joined AstraZeneca in 2011 as the Associate Director of Clinical Research, Respiratory and Inflammation. My new role allowed me to pursue my desire to help patients on a different level by guiding the development of medications. Some of the most rewarding parts about working at AstraZeneca are being able to drive the science that helps advance patient care and being at the forefront of advancements in respiratory disease therapies. Over the course of my career, I’ve been involved in numerous projects, including several respiratory clinical trials.
Shifting to a more general treatment landscape question, what do you think is on the horizon for the Inhaled space?
It’s an exciting time in pulmonary medicine. We're recognizing that asthma and COPD are heterogeneous diseases1, meaning that there’s not just one type of inflammation driving these diseases.
Our aim at AstraZeneca is to transform asthma and COPD treatment through Inhaled combinations at the core of care, precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. Because of the complexity of respiratory disease, we need different treatment and device options for patients. The use of such targeted therapies, on top of controller medication, may lead to better asthma control and less exacerbation risks in patients with asthma.
Switching gears, one of the brands you worked on over the course of your career is SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol. Can you tell us about this treatment option?
Combination products that contain an inhaled corticosteroid (ICS) and a long-acting beta2 adrenergic agonist (LABA), including SYMBICORT, are important medications for many patients2,3 and are a mainstay of inhalational therapy for asthma and COPD. AstraZeneca’s investment to fully explore indications in different populations shows our continued commitment to the respiratory space.
SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older.4 SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an ICS or whose disease warrants initiation of treatment with both an ICS and LABA.4
SYMBICORT 160/4.5 µg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations.4
SYMBICORT is not indicated for the relief of acute bronchospasm.4
What are some milestones that speak to SYMBICORT’s evolution over the past several years?
Last year was an important year of milestones for SYMBICORT because the FDA approved three label updates, made possible through several clinical trials. These included a safety/efficacy pediatric asthma indication trial in patients 6 to <12 years of age, a Phase 3b trial designed to support approval of the COPD exacerbation indication, which I helped design and execute, and a LABA post marketing safety study in asthma patients ≥12 years of age, which was part of an FDA-required class-wide clinical trial program conducted by manufacturers of ICS/LABAs that evaluated the risk of serious asthma-related events with ICS/LABA versus ICS alone.
In January 2017, SYMBICORT 80/4.5 µg was approved for the treatment of asthma in patients aged six up to 12 years. SYMBICORT 80/4.5 µg and 160/4.5 µg were already approved in the US to treat asthma in patients 12 years and older.5
In September 2017, SYMBICORT 160/4.5 µg was approved for reducing exacerbations in patients with COPD. This added to the previously approved indication of maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and/or emphysema.5
In December 2017, the US Food and Drug Administration (FDA) approved updates to the labeling for all ICS/LABA products, including SYMBICORT. These updates included removal of the Boxed WARNING for serious asthma-related outcomes.5 The ICS/LABA labels all retain a Warning and Precaution related to an increased risk of asthma-related death when LABAs are used without an ICS in the treatment of asthma.5 These label updates were a result of an FDA review of 4 post-marketing LABA safety studies conducted with ICS/LABA products, including the study with SYMBICORT.5
IMPORTANT SAFETY INFORMATION FOR SYMBICORT
SYMBICORT is indicated for the treatment of asthma in patients 6 years and older not adequately controlled on a long-term asthma-control medication such as an ICS or whose disease warrants initiation of treatment with both an ICS and LABA. (also see DOSAGE AND ADMINISTRATION).
SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and to reduce COPD exacerbations.
SYMBICORT is NOT indicated for the relief of acute bronchospasm.