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.


Subscribe or Register

Existing user? Login

First-in-class oral drug approved for psoriasis conditions in Europe

 Apremilast (Celgene’s Otezla) has been given European approval for the treatment of two psoriasis conditions.

Apremilast, an oral drug for psoriasis conditions, has been approved by the European Commission. Psoriasis (pictured) is an autoimmune disease

Source: Milan Lipowski / Alamy

Apremilast, a novel treatment for psoriasis, was well-tolerated in clinical trials, with adverse events being mostly mild-to-moderate.

The European Commission has authorised apremilast (Celgene’s Otezla), a first-in-class oral drug for the treatment of chronic plaque psoriasis and psoriatic arthritis in patients who have failed first-line systemic therapies, following its approval by the European Medicines Agency in November 2014. It was approved in the United States in March 2014 for the second-line treatment of plaque psoriasis.

Apremilast selectively inhibits phosphodiesterase-4, increasing intracellular levels of cyclic adenosine monophosphate (cAMP) and helping to downregulate the inflammatory response. Uniquely among treatments for psoriasis and psoriatic arthritis, Otezla is taken orally and does not require laboratory monitoring before or during treatment.

The drug is indicated for adults with moderate-to-severe chronic plaque psoriasis who have failed to respond to, who have a contraindication to, or who are intolerant of other systemic therapies. It is also indicated for use alone or in combination with disease-modifying antirheumatic drugs (DMARDs) for active psoriatic arthritis in adults who have had an inadequate response to, or who have been intolerant to, previous DMARD therapy.

The approval was based on clinical trial programmes that included some 1,250 patients with plaque psoriasis and around 1,500 patients with active psoriatic arthritis. In both diseases, apremilast showed superiority over placebo for the primary endpoints at week 16, with the clinical response being maintained to week 52.

Apremilast was well tolerated, with the most common adverse events being diarrhoea, nausea and infections of the upper respiratory tract. Adverse events were mostly mild-to-moderate and resolved without stopping treatment.

In the UK, the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium are reviewing the drug and are expected to issue guidance this year. Chris Edwards, a consultant rheumatologist from University Hospital Southampton NHS Foundation Trust, said in a Celgene company statement that apremilast was “a new, oral treatment that fills a real gap in the therapies available for patients”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067726

Readers' comments (1)

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

  • Pharmaceutical Statistics

    Pharmaceutical Statistics

    This book on basic statistics has been specifically written for pharmacy students.

    £33.00Buy now
  • 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

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.