AstraZeneca plc (ADR) (NYSE:AZN) has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding its Asthma candidate.
The CHMP which is part of the European Medicines Agency (EMA) gave the positive recommendation for the pipeline respiratory disease treatment, benralizumab, giving it the thumbs up for marketing approval. AstraZeneca has been seeking approval for use of the candidate drug as an add-on maintenance drug for treating adults with chronic eosinophilic asthma. The pipeline treatment is also pending approval in the U.S where it is currently undergoing the review process. The FDA is expected to provide an answer before the end of the year.
The CHMP’s opinion on benralizumab was based on the positive data that was presented from the pivotal tests involving the drug. The studies namely CALIMA and SIROCCO demonstrated a significant drop in the exacerbations and also noteworthy improvements in lung function for the patients that participated in the studies. The pipeline treatment is also undergoing evaluation for treating chronic obstructive pulmonary disease (COPD).
“This positive recommendation is an important step towards providing a next-generation treatment for severe, uncontrolled asthma patients with an eosinophilic phenotype. Benralizumab has the potential to make a real difference to patients with its combination of efficacy, speed of onset, convenience and the ability to reduce oral steroid use,” stated AstraZeneca’s Chief Medical Officer and Executive VP of Global Medicines Development.
Tim Harrison who specializes in Asthma and Respiratory Medicine at the University of Nottingham stated that millions of people in the world are affected by severe and uncontrolled asthma. The professor also stated that most of the patients who experience severe symptoms are usually at a higher risk of being hospitalized and even at the risk of death despite the fact that there are asthma treatments in the market. Harrison stated that Benralizumab is a unique because it is a new type of antibody that can potentially transform the situation for severe asthma patients.
AstraZeneca stock closed the latest trading session on Monday at $32.91 which was the same closing price in the previous trading session.