US FDA advisers recommend approval of Teva asthma drug for adults
NEW YORK – An advisory committee to the US Food and Drug Administration recommended that the agency approve Teva Pharmaceutical Industries Ltd’s <TEVA.TA) experimental drug reslizumab for severe asthma in patients aged 18 and older.
The panel voted unanimously that the drug should not be approved for children aged 12 to 17.
The FDA is not required to follow the advice of its expert advisory panels, but typically does so.
Reslizumab is an antibody drug designed to be given intravenously once every four weeks.
The FDA, according to a Teva spokeswoman, is slated to decide by March whether to approve the drug, which would be sold under the brand name Cinqair.
The agency last month approved a similar asthma drug, Nucala, or mepolizumab, which is produced by GlaxoSmithKline Plc, for patients age 12 and older.
Asthma is a chronic disease that causes inflammation in the airways of the lungs. According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the United States had asthma, and there are more than 400,000 asthma-related hospitalizations each year. -Reuters