Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 October 2014

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24/10/2014

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 October 2014

Six new medicines recommended for approval

Six new medicines have been recommended for approval at the October meeting of the Committee for Medicinal Products for Human Use (CHMP), two of which are for orphan conditions.

The European Medicines Agency has recommended granting a marketing authorisation under exceptional circumstances for Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria (EPP), a rare genetic disease which causes intolerance to light. Scenesse is the first medicine for patients with this condition. This type of authorisation is granted to medicines where comprehensive data on the medicine cannot be collected, for example, because the condition is too rare, or because the collection of full information is not possible or is unethical.

During the evaluation of Scenesse, the CHMP invited patients to share their experience of living with this condition. This is the first time that patients have been involved in CHMP discussions on the benefits and risks of a medicine. For more information please see the press release in the grid below.

The CHMP also gave a positive opinion for Lynparza (olaparib), a first-in-class medicine for the treatment of women with a subtype of ovarian cancer for which there are limited treatment options. Lynparza has an orphan designation. For more information please see the press release in the grid below.

Duavive (conjugated oestrogens / bazedoxifene) was recommended by the CHMP as a new treatment option for oestrogen deficiency.

Rixubis (nonacog gamma) received a positive opinion for the treatment and prophylaxis of bleeding in patients with haemophilia B.

The CHMP granted positive opinions for two informed consent applications: Duloxetine Lilly (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder, and Paliperidone Janssen (paliperidone) for the treatment of schizophrenia. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Recommendation on extension of therapeutic indication

The Committee recommended an extension of indication for Xtandi.

Outcome of two safety reviews

The CHMP has concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine for the treatment of leukaemia, and has recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries.

The Committee also reviewed the safety and efficacy of medicines containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to the product information of products for injection or inhalation to ensure their safe and effective use in the treatment of serious infections that are resistant to standard antibiotics.

More information on these reviews, and all other outcomes of the CHMP October 2014 meeting, is available in the grid below.

Agenda and minutes

The agenda of the October 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the November CHMP meeting.

CHMP statistics

Key figures from the October 2014 CHMP meeting are represented in the graphic below.

 

 

* This figure includes a withdrawn application adopted by written procedure after the July CHMP meeting. 


Positive recommendations on new medicines

Name of medicineDuavive
International non-proprietary name (INN)estrogens conjugated / bazedoxifene
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of oestrogen deficiency syndrome
More informationSummary of opinion for Duavive

 

Name of medicineLynparza
INNolaparib 
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of ovarian cancer
More informationSummary of opinion for Lynparza
 Press release: Lynparza recommended for approval in ovarian cancer

 

Name of medicineRixubis
INNnonacog gamma
Marketing-authorisation applicantBaxter Innovations GmbH
Therapeutic indicationTreatment and prophylaxis of bleeding in patients with haemophilia B
More informationSummary of opinion for Rixubis

 

Name of medicineScenesse
INNafamelanotide 
Marketing-authorisation applicantClinuvel (UK) Limited
Therapeutic indicationTreatment of phototoxicity 
More informationSummary of opinion for Scenesse
 Press release: Scenesse recommended for rare disease that causes intolerance to sunlight

 

Positive recommendations on new informed consent applications      

Name of medicineDuloxetine Lilly
INNduloxetine
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder
More informationSummary of opinion for Duloxetine Lilly

 

Name of medicinePaliperidone Janssen
INNpaliperidone
Marketing-authorisation applicantJanssen-Cilag International NV
Therapeutic indicationTreatment of schizophrenia
More informationSummary of opinion for Paliperidone Janssen

 

Positive recommendation on extension of therapeutic indication        

Name of medicineXtandi
INNenzalutamide
Marketing-authorisation holderAstellas Pharma Europe B.V.
More informationSummary of opinion for Xtandi

         

Public-health recommendations

Name of medicineIclusig
INNponatinib
Marketing-authorisation holderAriad Pharma Ltd
More informationEuropean Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig

 

Name of medicinePolymyxin-containing medicines
INNcolistin, colistimethate sodium
More information

European Medicines Agency completes review of polymyxin-based medicines

 

Outcome of arbitration procedure

Name of medicineOxynal, Targin and associated names
INNoxycodone / naloxone
Marketing-authorisation holderMundipharma GmbH
More informationQuestions and answers on Oxynal, Targin and associated names

 

Outcome of harmonisation procedure

Name of medicinePlendil
INNfelodipine
Marketing-authorisation holderAstra Zeneca group of companies and associated companies
More informationQuestions and answers on Plendil and associated names

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in October 2014 by the Name Review Group (NRG)
Organisational matters

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Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu