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

European Medicines Agency

EMA recommends seven new medicines for approval across the EU

Two orphan drugs are among the medicinal products given the green light by the European Medicines Agency.

EMA headquarters, London

Source: Shutterstock.com

Two orphan drugs are among the seven new medicinal products given the green light by the European Medicines Agency

Seven new medicines are being recommended for approval for use across the European Union following the latest meeting of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The committee agreed a new marketing authority for the advanced therapy medicinal product darvadstrocel (Alofisel) — which has an orphan designation — for the treatment of complex perianal fistulas in patients with Crohn’s disease.

A paediatric-use marketing authorisation was granted for the hydrocortisone Alkindi, for the treatment of the rare disorder primary adrenal insufficiency.

A conditional marketing authorisation for burosumab (Crysvita) — which has orphan drug designation — for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children and adolescents with growing skeletons was also recommended for approval.

Semaglutide, marketed as Ozempic, received a positive opinion for the treatment of type 2 diabetes.

The biosimilar trastuzumab (Herzuma), for the treatment of breast and gastric cancer, was also recommended for approval.

Two generic medicines received a positive CHMP opinion: anagrelide (Anagrelide Mylan) for the reduction of elevated platelet counts in at-risk essential thrombocythaemia patients, and efavirenz/emtricitabine/tenofovir disoproxil (Efavirenz/Emtricitabine/Tenofovir disoproxil Krka) for the treatment of HIV infection.

Other announcements

But the committee reached a negative opinion for the new medicine plitidepsin, branded as Apilidin, which was seeking approval for the treatment of patients with multiple myeloma.

The committee also reported the findings of its safety review of mycophenolate medicines, which are taken to prevent the rejection of transplanted organs.

According to current evidence there is no risk of malformation to the foetus or miscarriage in pregnant women if their male partner takes these drugs, it concluded.

However, it felt that the risk could not be completely ruled out and recommended that either the male patient or female partner use reliable contraception.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20204162

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

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Patient Care in Community Practice

    Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00Buy now
  • Drugs of Abuse

    Drugs of Abuse

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

    £38.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy 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

Newsletter Sign-up

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