Healthcare company AstraZeneca Plc (AZN,AZN.L) Thursday stated that it is looking forward to work with the U.S. Food and Drug Administration to execute a study design to answer critical questions regarding the appropriate use of long-acting beta-agonist, or LABA, containing products, including the company's Symbicort, for the treatment of asthma.
According to the company, on March 10 and 11, the Joint Advisory Committees of the FDA, including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees discussed the design of post-marketing safety studies for LABA containing products in the U.S., including Symbicort.
AstraZeneca's Symbicort is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older. Administered twice daily, Symbicort combines two respiratory medications, budesonide, an inhaled corticosteroid, and formoterol, a LABA.
Symbicort 160/4.5 mcg is also indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and emphysema.
As per the company's safety warning, LABA may increase the risk of asthma-related death. Symbicort is not a rescue medication. It should only be used for patients with asthma not adequately controlled on other asthma controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.
Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, stated that the company has witnessed over the past two days many challenges in designing and executing a relevant, feasible and ethical post-marketing safety study that answers FDA's question regarding LABA-containing products.
AstraZeneca said that it is confident in the positive benefit-risk profile of Symbicort in asthma as demonstrated by clinical data and patient experience. The company also supports ongoing scientific discussion to address any outstanding questions regarding the use of combination LABA and inhaled corticosteroid products for the treatment of asthma.
AZN closed Thursday's trading at $43.99, down $0.39 or 0.88%, on a volume of 1.72 million shares.
On the LSE, AZN.L ended at 2,933 pence on Thursday, down 17 pence, on a volume of 3.69 million shares.
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