Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015

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23/10/2015

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015

Advanced therapy medicinal product for melanoma receives positive opinion

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an advanced therapy medicine for marketing authorisation at its October 2015 meeting.

Imlygic (talimogene laherparepvec) is a medicine for the treatment of adults with melanoma that cannot be removed by surgery and that has spread either to the surrounding area or to other areas of the body without affecting the bones, brain, lung or other internal organs. Imlygic is a first-in-class advanced therapy medicinal product (ATMP) derived from a virus that has been genetically engineered to infect and kill cancer cells. For more information on Imlygic, please see the press release in the grid below.

Seven recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Cubicin, Edurant, Emend, Volibris, Xalkori and two extensions of indication for Cosentyx.

Re-examination procedure concluded

The CHMP concluded a re-examination procedure, issuing a final negative opinion for Heparesc (human heterologous liver cells). A question-and-answer document on this opinion is available below.

Inductos to be suspended in the EU

The Committee recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures, due to manufacturing issues. Although no risk to patients has been identified, Inductos will remain suspended until issues with the manufacturing site for one of its components (an absorbable sponge) are resolved. For more information, please see the public health communication in the grid below.

Outcome of periodic safety review: Cellcept

The CHMP warned that the transplant medicine mycophenolate (authorised centrally as CellCept and nationally under various names) must not be used in pregnancy unless no alternative is available. This follows a routine re-assessment of the benefits and risks of these medicines, which provided updated evidence on the risk of birth defects and spontaneous abortions when pregnant women were exposed to these medicines. For more information, please see the public health communication in the grid below.

New advice for doctors and patients on Tecfidera

The CHMP gave new advice for doctors and patients to minimise the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with the multiple sclerosis medicine Tecfidera (dimethyl fumarate). For more information, please see the public health communication in the grid below.

Update to safety information for medicines for the treatment of HIV infection

The CHMP has updated the advice on the risk of body fat changes and lactic acidosis with medicines for the treatment of human immunodeficiency virus (HIV) infection. As a result, HIV medicines will no longer require a warning concerning fat redistribution in their product information, and a number of medicines of the class ‘nucleoside and nucleotide analogues’ will no longer require a warning about lactic acidosis. For more information, please see the public health communication in the grid below.

Withdrawal of application

An application for marketing authorisation for VeraSeal (human fibrinogen / human thrombin) has been withdrawn. A question-and-answer document on this withdrawal is available below.

Agenda and minutes

The agenda of the October 2015 meeting is published on EMA’s website. Minutes of the September 2015 CHMP meeting will be published next week.

CHMP statistics

Key figures from the October 2015 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s October 2015 meeting, is available in the grid below. 

CHMP_highlights_October_2015

Download image in PDF format

 

Positive recommendation on new medicine

Name of medicineImlygic
International non-proprietary name (INN)talimogene laherparepvec
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of adults with melanoma
More information

Summary of opinion for Imlygic

 

Press release: First oncolytic immunotherapy medicine recommended for approval

 

Re-examination of recommendation for new medicine

Name of medicineHeparesc
INNhuman heterologous liver cells
Marketing-authorisation applicantCytonet GmbH Co KG
Therapeutic indicationTreatment of urea cycle disorders
More informationQuestions and answers on refusal of marketing authorisation for Heparesc

 

Positive recommendations on extensions of therapeutic indications

Name of medicineCosentyx
INNsecukinumab
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion on Cosentyx

 

Name of medicineCubicin
INNdaptomycin
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion on Cubicin

 

Name of medicineEdurant
INNrilpivirine
Marketing-authorisation holderJanssen-Cilag International N.V.
More informationSummary of opinion on Edurant

 

Name of medicineEmend
INNaprepitant
Marketing-authorisation holderMerck Sharp & Dohme Limited
More informationSummary of opinion on Emend

 

Name of medicineVolibris
INNambrisentan
Marketing-authorisation holderGlaxo Group Ltd
More informationSummary of opinion on Volibris

 

Name of medicineXalkori
INNcrizotinib
Marketing-authorisation holderPfizer Limited
More informationSummary of opinion on Xalkori

 

Public health recommendations

Name of medicineAntiretroviral medicinal products
More informationUpdated advice on body fat changes and lactic acidosis with HIV medicines

 

Name of medicineCellcept
More informationEMA recommends additional measures to prevent use of mycophenolate in pregnancy

  

Name of medicineInductos
More informationInductos to be suspended in the EU

 

Name of medicineTecfidera
More informationUpdated recommendations to minimise the risk of the rare brain infection PML with Tecfidera

  

Withdrawal of application

Name of medicineVeraSeal
INNhuman fibrinogen, human thrombin
More informationQuestions and answers on VeraSeal

 

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 September 2015 by the Name Review Group (NRG)
Organisational matters

 

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