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

 

London, UK (October 23, 2015) – 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.

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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.

 

 

Key figures from the October 2015 CHMP meeting are represented in the graphic. Copyright: EMA 

 

 

 

 

Positive recommendation on new medicine

 

Name of medicine

Imlygic

International non-proprietary name (INN)

talimogene laherparepvec

Marketing-authorisation applicant

Amgen Europe B.V.

Therapeutic indication

Treatment 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 medicine

Heparesc

INN

human heterologous liver cells

Marketing-authorisation applicant

Cytonet GmbH Co KG

Therapeutic indication

Treatment of urea cycle disorders

More information

Questions and answers on refusal of marketing authorisation for Heparesc

 

 

Positive recommendations on extensions of therapeutic indications

 

Name of medicine

Cosentyx

INN

secukinumab

Marketing-authorisation holder

Novartis Europharm Ltd

More information

Summary of opinion on Cosentyx

 

Name of medicine

Cubicin

INN

daptomycin

Marketing-authorisation holder

Novartis Europharm Ltd

More information

Summary of opinion on Cubicin

 

Name of medicine

Edurant

INN

rilpivirine

Marketing-authorisation holder

Janssen-Cilag International N.V.

More information

Summary of opinion on Edurant

 

Name of medicine

Emend

INN

aprepitant

Marketing-authorisation holder

Merck Sharp & Dohme Limited

More information

Summary of opinion on Emend

 

Name of medicine

Volibris

INN

ambrisentan

Marketing-authorisation holder

Glaxo Group Ltd

More information

Summary of opinion on Volibris

 

Name of medicine

Xalkori

INN

crizotinib

Marketing-authorisation holder

Pfizer Limited

More information

Summary of opinion on Xalkori

 

 

Public health recommendations

 

Name of medicine

Antiretroviral medicinal products

More information

Updated advice on body fat changes and lactic acidosis with HIV medicines

 

Name of medicine

Cellcept

More information

EMA recommends additional measures to prevent use of mycophenolate in pregnancy

  

Name of medicine

Inductos

More information

Inductos to be suspended in the EU

 

Name of medicine

Tecfidera

More information

Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera

  

 

Withdrawal of application

 

Name of medicine

VeraSeal

INN

human fibrinogen, human thrombin

More information

Questions and answers on VeraSeal

 

 

Other updates

 

  • Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
  • Opinions on safety variations
  • Guidelines and concept papers adopted
  • Organisational matters
  • Opinions on consultation procedures on ancillary medicinal substances in medical devices

 

 


European Medicines Agency, 23.10.2015 (tB).

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