Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Cinqair to Treat Severe Asthma

FDA news release; 2016 March 23

The FDA has approved Cinqair (reslizumab) for use with asthma medicines for the maintenance treatment of severe asthma in patients aged ≥18 years. Cinqair reduces severe asthma by reducing the levels of blood eosinophils, a type of white blood cell that contributes to the development of asthma.

Indications: Cinqair is approved for patients who have a history of severe attacks (exacerbations) despite receiving their current asthma medications.

Dosage/administration: Cinqair is administered once every 4 weeks via intravenous infusion by a health care professional in a clinical setting prepared to manage anaphylaxis. It is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in murine myeloma non-secreting 0 (NSO) cells.

Adverse reactions: The most common side effects in clinical trials for Cinqair included anaphylaxis, cancer, and muscle pain.

Citation: US Food and Drug Administration. FDA approves Cinqair to treat severe asthma. FDA Web site. March 23, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491980.htm. Accessed March 28, 2016.