Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Medicines licensing

Injectable asthma drug reslizumab approved by European Commission

The European Commission has approved a marketing authorisation for reslizumab (Teva Pharmaceutical Industries’ Cinqaero), an injectable treatment for use in severe asthma. 

The decision follows a recommendation in June 2016 by the European Medicines Agency’s Committee for Medicinal Products that marketing authorisation be granted for use as an add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product. The drug was approved for use in the United States in March 2016.

Clinical trials have shown that Cinqaero is able to reduce the exacerbation rate and improve lung function and asthma-related quality of life in patients with severe eosinophilic asthma (with blood eosinophil count ≥ 400 cells/µL) and with at least one previous asthma exacerbation in the preceding year. 

Cinqaero will be available as a 10mg/ml concentrate for solution for infusion, which is administered at clinics every four weeks. 

Reslizumab is a humanized interleukin-5 antagonist monoclonal antibody. It binds specifically to IL5, a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils, which means that survival and activity of eosinophils are reduced. 

The most common side effects are increased blood creatine phosphokinase, myalgia and anaphylactic reactions. An imbalance in malignant neoplasms was observed between placebo and treatment arms during the clinical trials. 

Guy Brusselle from Ghent University Hospital, Belgium, an investigator in one of the clinical trials, says: “For patients living with severe asthma, there is a significant unmet need when it comes to treatment options, despite today’s standard of care. It is exciting and encouraging to see the approval of Cinqaero in Europe as physicians seek targeted treatment options for this specific subset of patients living with uncontrolled severe eosinophilic asthma.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201609

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now
  • Paediatric Drug Handling

    Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00Buy now
  • Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics covers all aspects of drug use in renal failure. Shows the role of the pharmacist in patient care for chronic kidney disease.

    £38.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.