FDA Alert: Teva’s Cinqair Approved for Severe Asthma

The biologic drug reslizumab (marketed as Cinqair by Teva) is now approved by the Food and Drug Administration (FDA) for use with other asthma drugs for maintenance treatment of severe asthma in adults with a history of severe exacerbations despite treatment with other medications.

Reslizumab targets IL-5 to reduce blood levels of eosinophils, believed to contribute to asthma exacerbations.

FDA's Pulmonary and Allergy Drugs Advisory Committee voted 11 to 3 to recommend approval of the drug for use in adults with moderate to severe asthma last December. They unanimously voted against approval for use in children, citing uncertainties about the drug's safety profile and efficacy in the pediatric setting. The panel noted that very few children had been included in reslizumab clinical trials.

Read the full FDA press release here.

Looking for More Education on Newly Approved Biologics? Attend The Life Spectrum of Asthma, July 29-31 in Chicago

It is crucially important for allergist/immunologists, as specialists in the diagnosis and management of asthma, to understand how to select the most appropriate patients for the use of immune response modifiers and how to assess and manage the risk-benefit ratio of treatment.

The Life Spectrum of Asthma, July 29-31 at the Sheraton Grand Chicago, will provide you with a comprehensive understanding of how to do exactly that, by incorporating cutting-edge science and discussion of newly approved biologic therapies and those coming down the pipe. Learn more about the course here.

Did you know that fellows-in-training and allied health members can register for The Life Spectrum of Asthma at a discounted rate? Contact cme@aaaai.org to register at this exclusive $100 rate.