FDA Gives Teva Go-Ahead on Asthma Drug

YERUSHALAYIM -

The U.S. Food and Drug Administration (FDA) has announced approval of a new asthma treatment developed by the Israeli-based firm Teva, Globes reported on Sunday.

CINQAIR injection for severe asthma sufferers is taken once every four weeks to control the symptoms.

The product is expected to become commercially available to patients, by prescription, as soon as the second quarter of 2016.

“Despite ongoing treatment with today’s standard of care, many patients with severe asthma remain inadequately controlled, the implications of which can lead to increased exacerbations and hospitalization,” said Professor Mario Castro, Washington University School of Medicine, Division of Pulmonary and Critical Care Medicine and lead investigator.

“The approval of CINQAIR marks an important advancement in the treatment paradigm for asthma, as the therapy has demonstrated significant improvement in multiple measures of asthma control.”

Clinical studies indicated that CINQAIR was associated with reduction in asthma exacerbations of up to 59% as well as significant improvement in lung function, symptoms, and asthma-related quality of life.

The most common unwanted side-effect (in two or more percent of patients) was oropharyngeal pain.

The FDA go-ahead marks the first approval of CINQAIR (reslizumab) in the world. Reslizumab has been submitted to and is currently under review by European Medicines Agency (EMA) and Health Canada.