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

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	CHMP 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 the marketing authorisation for Heparesc (human heterologous liver cells)

Positive recommendations on extensions of therapeutic indications

Name of medicine	Cosentyx
INN	secukinumab
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Cosentyx

Name of medicine	Cubicin
INN	daptomycin
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Cubicin

Name of medicine	Edurant
INN	rilpivirine
Marketing-authorisation holder	Janssen-Cilag International N.V.
More information	CHMP post-authorisation summary of positive opinion for Edurant

Name of medicine	Emend
INN	aprepitant
Marketing-authorisation holder	Merck Sharp & Dohme Limited
More information	CHMP post-authorisation summary of positive opinion for Emend

Name of medicine	Volibris
INN	ambrisentan
Marketing-authorisation holder	Glaxo Group Ltd
More information	CHMP post-authorisation summary of positive opinion for Volibris

Name of medicine	Xalkori
INN	crizotinib
Marketing-authorisation holder	Pfizer Limited
More information	CHMP post-authorisation summary of positive opinion for 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 the withdrawal of the marketing authorisation application for VeraSeal (human fibrinogen / human thrombin)