Human Medicines Highlights: Issue 24 - January 2011

Positive CHMP recommendations* on new medicines

• Trobalt (retigabine)
  • Treatment of epilepsy
• Gilenya (fingolimod)
  • Treatment of multiple sclerosis (MS)

Negative CHMP recommendation

• Fampyra (fampridine)
  • Intended for the treatment of multiple sclerosis
• Movectro (cladribine)
  • Intended for the treatment of multiple sclerosis

* In order to obtain a Community authorisation to market a medicine (centralised procedure), an application must be submitted to the European Medicines Agency. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency carries out a scientific evaluation and prepares a scientific opinion (recommendation). The opinion is sent to the European Commission which issues a Decision and grants a marketing authorisation.

Any positive opinion given by the CHMP is published in the first instance as a “Summary of Opinion”. More detailed information is published later, following the granting of a Marketing Authorisation by the European Commission as an European Public Assessment Report (EPAR).

Positive CHMP recommendations* on new medicines

• Jevtana (cabazitaxel)
  • Treatment of prostate cancer
• Halaven (eribulin)
  • Treatment of breast cancer

New marketing authorisations

• Potactasol (topotecan)
  • Treatment of metastatic cancer of the ovary and small cell lung cancer

Withdrawal of marketing authorisation applications

• Tekinex (omacetaxine mepesuccinate)
  • Intended for the treatment of Philadelphia chromosome-positive chronic myeloid leukaemia (CML)

* In order to obtain a Community authorisation to market a medicine (centralised procedure), an application must be submitted to the European Medicines Agency. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency carries out a scientific evaluation and prepares a scientific opinion (recommendation). The opinion is sent to the European Commission which issues a Decision and grants a marketing authorisation.

Any positive opinion given by the CHMP is published in the first instance as a “Summary of Opinion”. More detailed information is published later, following the granting of a Marketing Authorisation by the European Commission as an European Public Assessment Report (EPAR).

New marketing authorisations

• Aflunov (prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted))
  • Vaccination against influenza (H5N1)

Withdrawal of marketing authorisations

• Arepanrix (pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted))
  • Vaccination against influenza
• ImmunoGam (human hepatitis B immunoglobulin)
  • Vaccination against the hepatitis B virus

New information on authorised medicines

• Baraclude (entecavir) – new indication
  • Treatment of chronic hepatitis B virus (HBV) infection
• Prezista (darunavir) – extension of indication
  • Treatment of HIV-1

Arbitration procedures

• Famvir (famciclovir) – harmonisation of SmPC, labelling and PL
  • Treatment of infection with herpes viruses
• Valtrex (valaciclovir) – harmonisation of SmPC, labelling and PL
  • Treatment of infection with herpes viruses

New marketing authorisations

• Leflunomide ratiopharm (leflunomide)
  • Treatment of active rheumatoid arthritis

Withdrawal of marketing authorisation applications

• Ozespa (briakinumab)
  • Intended for the treatment of moderate to severe chronic plaque psoriasis

Positive CHMP recommendations* on new medicines

• Riprazo HCT (aliskiren / hydrochlorothiazide)
  • Treatment of essential hypertension
• Pravafenix (fenofibrate / pravastatin)
  • Treatment of patients with mixed dyslipidaemia at high risk of coronary heart disease (CHD)

New marketing authorisations

• Possia, Brilique (ticagrelor)
  • Prevention of atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes

New information on authorised medicines

• INOmax (nitric oxide) – new indication
  • Treatment of pulmonary hypertension

Safety communication update

• Multaq (dronedarone)
  • Q&A

* In order to obtain a Community authorisation to market a medicine (centralised procedure), an application must be submitted to the European Medicines Agency. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency carries out a scientific evaluation and prepares a scientific opinion (recommendation). The opinion is sent to the European Commission which issues a Decision and grants a marketing authorisation.

Any positive opinion given by the CHMP is published in the first instance as a “Summary of Opinion”. More detailed information is published later, following the granting of a Marketing Authorisation by the European Commission as an European Public Assessment Report (EPAR).

Withdrawal of marketing authorisation applications

• Zenhale (formoterol / mometasone)
  • Treatment of asthma

Other information

• Ionsys (fentanyl) - Non-renewal of the marketing authorisation in the European Union
  • Management of acute moderate to severe post-operative pain

Safety communication update

• Peritoneal dialysis solutions Dianeal, Extraneal and Nutrineal
  • Press release

Guidelines open for consultation

• Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available
  Deadline for comments: 31 March 2011
• Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population
  Deadline for comments: 15 April 2011

Scientific committees' activities

• CHMP monthly report from the December 2010 meeting
• CHMP monthly report from the January 2011 meeting
• CAT monthly report from the January 2011 meeting
• COMP monthly report from the January 2011 meeting
• PDCO monthly report from the January 2011 meeting
• PhVWP monthly report from the December 2010 meeting
• PhVWP monthly report from the January 2011 meeting
• Work plan CHMP Working Group with Healthcare Professionals' Organisations (HCP WG) 2011
• Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)

Other publications

• New membership list published for the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
• Recognition criteria for self assessment - Enpr-EMA: International Pediatric Transplant Association (IPTA)
• Medicinal products for human use: Monthly figures - December 2010
• Medicinal products for human use: Monthly figures - November 2010
• Calendar of 2011 dates for the European Medicines Agency
• European Medicines Agency opens public discussion on need for active control in clinical trials
• Guide to the European Medicines Agency
• Organisation chart of the European Medicines Agency
• EMA conference: "Regulatory science: are regulators leaders or followers?", EMA, London, UK, 15-Dec-2010
• Report published on the uses of medicines for children in the European Union
• Road map to 2015: The European Medicines Agency's contribution to science, medicines and health
• Q&A: Generic/hybrid applications