European Medicines Agency

Ten new medicines recommended for approval by EMA

Drugs for the treatment of multiple sclerosis, HIV-1 infection and metastatic breast cancer are among those put forward for approval.

At its most recent meeting the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval, including one biosimilar and two orphan medicines.

Ocrelizumab (Ocrevus; Roche) for the treatment of adults with relapsing multiple sclerosis and early primary progressive multiple sclerosis; darunavir (Darunavir Krka and Darunavir Krka d.d; Novo mesto), for the treatment of HIV-1 infection; and fulvestrant (Fulvestrant; Mylan), for the treatment of locally advanced or metastatic breast cancer, were among the ten medicines recommended.

Others included the orphan drugs budesonide (Jorveza; Dr. Falk Pharma GmbH), for the treatment of eosinophilic oesophagitis, which was reviewed under EMA’s accelerated assessment mechanism, and letermovir (Prevymis; Merck), which prevents cytomegalovirus reactivation and disease in patients receiving immunosuppressants.

Rurioctocog alfa pegol (Adynovi; Baxalta) also received a positive opinion from the CHMP for the treatment of prophylaxis of bleeding in patients aged 12 years and above with haemophilia A, as did benralizumab (Fasenra; AstraZeneca) for the treatment of severe eosinophilic asthma, and prasterone (Intrarosa; Endoceutics) for the treatment of vulvar and vaginal atrophy in postmenopausal women.

Bevacizumab (Mvasi; Amgen), for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix, was the only biosimilar in the list.

Further recommendations

In the meeting the CHMP also re-examined two negative recommendations for the antipsychotic iloperidone (Fanaptum; Vanda Pharmaceuticals) and advanced breast cancer drug etirinotecan pegol (Onzeald; Nektar), adopted during the CHMP’s July 2017 meeting.

The CHMP confirmed its decision to refuse the granting of marketing authorisations for both drugs on the grounds that etirinotecan pegol’s benefit in the treatment of advanced breast cancer that had spread to the brain and other parts of the body had not been sufficiently demonstrated and because of concerns about the adverse effects of iloperidone. There were no new negative opinions on new medicines during the November 2017 meeting.

Furthermore, the committee recommended extensions of indications for four drugs, including cancer drug brentuximab vedotin (Adcetris; Takeda); once-a-day HIV-1 complete treatment elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya; Gilead Sciences); romiplostim (Nplate; Amgen); and cystic fibrosis combination treatment, lumacaftor/ivacaftor (Orkambi; Vertex Pharmaceuticals).

The CHMP also concluded its review of the multiple sclerosis medicine daclizumab (Zinbryta; Biogen Idec) and confirmed further restrictions to reduce the risk of serious liver damage.

Finally, two applications for initial marketing authorisations were withdrawn. These were for bevacizumab (Kyomarc; Amgen), which was intended to be used for the treatment of a number of different cancers, and sirukumab (Plivensia; Janssen-Cilag), which was intended to be used to treat rheumatoid arthritis.

The agenda for this meeting, held from 6 to 9 November 2017, is published on the  and the minutes will be published in due course.

Citation: The Salvadore DOI: 10.1211/PJ.2017.20203942

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

    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.

    £133.00
  • 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.

    £252.00
  • International Research in Healthcare

    Guidance for students or researchers undertaking a multi-centre research project in health services, medicines use and professional practice.

    £38.00
  • Nurse Prescribers' Formulary

    Essential reference for Community Practitioner Nurse Prescribers. Provides an overview of common conditions and details of medicines that may be prescribed.

    £17.99
  • BNF for Children (BNFC) 2018-2019

    The BNFC contains essential practical information for all healthcare professionals involved in prescribing, dispensing, monitoring and administration of medicines to children.

    £57.50

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

Powered by MedicinesComplete

Supplementary images

  • european medicines agency ss 17

Jobs you might like

  • South West England

Newsletter Sign-up

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

http://avtomaticheskij-poliv.com.ua

www.steroid-pharm.com/decabol.html

www.rezeptfrei-viagra.com